Food, drugs, devices › Encore Medical, LP

Device recall: AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3.

FDA enforcement event 88223 · Class II · initiated 28 Jun 2021 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordAustin, TX

Encore Medical, LP (Austin, TX) initiated this device recall on 28 Jun 2021; FDA lists 1 product record under event 88223, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Encore Medical, LP has 61 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Encore Medical, LP, Austin, TX.

Reason for recall

"Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery."

Distribution

"US: AL,AR,AZ,CA,CO,FL,GA,HI,IL,IN,KY,LA,MD,ME,MI,MN,MO,MS,MT,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,TN,TX,UT,VA,WA,WV OUS: N/A"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2331-2021	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	N/A	Class II	Ongoing	1 Sep 2021

Context

89%of 2021 device events are Class II900 events that year

1product record in this eventfirm median: 1

61events on this register for the firm

Other enforcement events for Encore Medical, LP

Initiated	Product (first record)	Type	Class	Records
16 Feb 2026	Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Descr	Device	Class II	2
15 Jan 2026	Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Mode	Device	Class II	3
5 Jan 2026	EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705	Device	Class II	2
18 Jul 2025	Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Produ	Device	Class II	4
9 Jul 2025	Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 34	Device	Class II	2
12 Jun 2025	Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog	Device	Class II	2
2 Jun 2025	Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number:	Device	Class II	2
28 May 2025	Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126	Device	Class II	4
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
10 Dec 2024	EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706	Device	Class II	1

All 61 events for Encore Medical, LP

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US: AL,AR,AZ,CA,CO,FL,GA,HI,IL,IN,KY,LA,MD,ME,MI,MN,MO,MS,MT,NM,NV,NY,OH,OK,OR,PA,PR,RI,SC,TN,TX,UT,VA,WA,WV OUS: N/A"

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.