Encore Medical, LP: FDA recalls

FDA enforcement reports name Encore Medical, LP as the recalling firm in 61 events. The events have 99 product records. The recalls started from 2012 to 2026. All the events are device recalls.

See the 61 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Enforcement events

61 events, newest first.

FDA enforcement events of Encore Medical, LP
Initiated	Product (first record)	Type	Class	Records	Status
16 Feb 2026	Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.	Device	Class II	2	Ongoing
15 Jan 2026	Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432	Device	Class II	3	Ongoing
5 Jan 2026	EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705	Device	Class II	2	Ongoing
18 Jul 2025	Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-Sterile	Device	Class II	4	Ongoing
9 Jul 2025	Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total knee replacements are not…	Device	Class II	2	Ongoing
12 Jun 2025	Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number: 952-28-40E Software Version: NA Product Description: The EMPOWR Dual Mobility" system is compatible with the EMPOWR Acetabular system, 28mm femoral heads and all hip stems Component: NA	Device	Class II	2	Ongoing
2 Jun 2025	Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis" knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total…	Device	Class II	2	Ongoing
28 May 2025	Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version: NA Product Description: Encore Medical L.P. shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use. While…	Device	Class II	4	Ongoing
18 Dec 2024	EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703	Device	Class II	1	Ongoing
10 Dec 2024	EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706	Device	Class II	1	Ongoing
10 Nov 2023	DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108 For the treatment of patients who are candidates for knee arthroplasty per the Indication for use.	Device	Class II	1	Ongoing
5 Oct 2023	Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797	Device	Class II	2	Completed
29 Sep 2023	DJO EMPOWR Knee Punch Handle, REF: 801-05-040	Device	Class II	1	Ongoing
25 Sep 2023	RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.	Device	Class II	2	Ongoing
6 Sep 2023	RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.	Device	Class II	1	Ongoing
22 Aug 2023	REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130	Device	Class II	1	Ongoing
22 Aug 2023	EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705	Device	Class II	2	Ongoing
4 Aug 2023	DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106	Device	Class II	5	Ongoing
28 Feb 2023	EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108	Device	Class II	1	Ongoing
22 Dec 2022	EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 8, 22MM, REF: 346-22-708; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 9, 22MM, REF: 346-22-709; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 10, 22MM, REF: 346-22-710; EMPOWR…	Device	Class II	1	Ongoing
12 Aug 2022	EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.	Device	Class II	2	Ongoing
5 May 2022	DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708	Device	Class II	1	Ongoing
28 Jun 2021	AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-12-000, 4. Part # 520-14-000, 5. Part # 520-16-000	Device	Class II	1	Ongoing
12 May 2021	DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. 11 12mm, CE0086, Sterile H2O2, UDI: (01)00888912166980	Device	Class II	2	Ongoing
5 Feb 2021	DJO EMPOWR KNEE Femoral Sizer	Device	Class II	1	Ongoing
9 Sep 2020	EMPOWR Acetabular System * EMPOWR Acetabular Cup, Cluster Hole, 54G * Size 54G 54 mm Dia./Cluster Hole Alpha Code G Liner P2 Porous Coated REF 940-02-54G - Product Usage: are intended for treatment of patients who are candidates for total hip arthroplasty per the indications for use.	Device	Class II	1	Ongoing
31 Aug 2020	AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part Number: 509-03-044 - Product Usage: Per IFU, DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the Indication for use.	Device	Class II	1	Terminated
7 Aug 2020	RSP Standard HUMERAL SOCKET INSERT, 44MM, HXe-Plus, Part No. 509-00-044	Device	Class II	2	Ongoing
3 Aug 2020	DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately sized Tibial Punch Guides to broach the tibial canal in preparation for the tibial baseplate keel.	Device	Class II	1	Ongoing
19 Jun 2020	EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007.	Device	Class II	2	Ongoing
22 Oct 2019	EMPOWR Acetabular System, Non-Sterile, Model Numbers 803-15-023 803-15-026 803-15-027 803-15-028 803-15-029 803-15-030 Product Usage: The EMPOWR Acetabular Impactor Balls is intended for use in joint replacement in patients suffering from disability due to noninflammatory degenerative joint disease including…	Device	Class II	1	Ongoing
4 Feb 2019	EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument tray FA EMP PAT TOOL KIT Part # 800-99-096	Device	Class II	1	Ongoing
21 Sep 2018	Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085	Device	Class II	1	Terminated
19 Sep 2018	Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.	Device	Class II	1	Ongoing
10 Jul 2018	djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.	Device	Class II	1	Ongoing
26 Jun 2018	Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used to facilitate cleaning and sterilization of the instrumentation by end users.	Device	Class II	1	Terminated
14 May 2018	Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.	Device	Class II	1	Terminated
30 Jan 2018	AltiVate Reverse INSTRUMENTATION, HUMERAL SOCKET SHELL TRIAL, STANDARD, REF 804-06-152, Qty: 01, Encore Medical, LP Orthopedic surgical instrument. Product Usage: The humeral socket shell trial is used to replicate/trial the shell geometry of the AltiVate Reverse Standard Shell Humeral Stem implants. It assembles to…	Device	Class II	1	Terminated
29 Jan 2018	Altivate Anatomic(TM) INSTRUMENTATION, PEGGED GLENOID TRIAL, SIZE 38mm, REF 804-07-380 Product Usage: The AltiVate Anatomic Shoulder System is a total shoulder system indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction.	Device	Class II	5	Completed
12 Dec 2017	DJO EMPOWR KNEE LOCKING TIBIAL PUNCH GUIDE, REF 801-05-042, NON STERILE, Qty 1 For use in orthopedic surgery.	Device	Class II	4	Terminated
15 Sep 2017	EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is…	Device	Class II	2	Terminated
4 Aug 2017	MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: REF S-200956 - 5mm PIN, SIZE 46 REF S-200957 - 5mm PIN, SIZE 50 REF S-200958 - 5mm PIN, SIZE 58	Device	Class II	1	Terminated
26 Jun 2017	Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of…	Device	Class II	4	Ongoing
31 May 2017	3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is…	Device	Class II	2	Terminated
9 Feb 2017	Turon Impaction Fixture	Device	Class II	2	Terminated
10 Jan 2017	LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized during the implantation phase by a safety screw. This system is particularly indicated for revision surgery on both…	Device	Class II	1	Terminated
10 Jan 2017	Empowr PS Knee Tibial Insert; Model 343-14-709 The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base implants.	Device	Class II	1	Terminated
15 Nov 2016	Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.	Device	Class II	1	Terminated
19 Sep 2016	Empowr PS Knee System Box Cut Guide The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant	Device	Class II	1	Terminated
19 Sep 2016	Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant.	Device	Class II	1	Terminated
26 Jul 2016	Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.	Device	Class II	1	Terminated
21 Jun 2016	MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636	Device	Class II	1	Terminated
8 Dec 2015	AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.	Device	Class II	1	Terminated
16 Sep 2015	Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.	Device	Class II	1	Terminated
15 Sep 2015	AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemented or cementless use. This device may also be indicated in the salvage of previously failed surgical attempts. Shoulder…	Device	Class II	1	Terminated
14 Sep 2015	Turon Shoulder Impaction Fixture REF 804-15-102 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then subsequently to assemble the Humeral Stem to the Head/Neck…	Device	Class II	2	Terminated
24 Jun 2015	FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139	Device	Class II	1	Terminated
1 Apr 2013	3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.	Device	Class II	1	Terminated
28 Sep 2012	6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.	Device	Class II	1	Terminated
9 Aug 2012	3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other…	Device	Class II	1	Terminated
16 Jul 2012	djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Encore Medical, LP: events for each product type
Type		Events
Device		61

Encore Medical, LP: events in each class
Class		Events
Class II		61

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 33

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Encore Medical, LP, by the year that the recall started. The largest year is 2023, with 9 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Encore Medical, LP: FDA recalls. https://recallregister.com/firm/encore-medical-lp/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
State of the firm address: TX

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Encore Medical, LP have?: Class II: 61 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Encore Medical, LP?: FDA event 98700, which the firm started on 16 Feb 2026. The first product in the record is: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis knee devices are intended for knee arthroplasty.
How many FDA recalls of Encore Medical, LP have the status Ongoing?: 33 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.