Device recall: EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705

Class II FDA enforcement event 98177. Recall start date: 5 Jan 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.

Class II, in the words of FDA

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

Encore Medical, LP started this device recall on 5 Jan 2026. The firm address in the FDA record is in Austin, TX. FDA put the recall in Class II. FDA event 98177 has 2 product records. The first FDA enforcement report date is 11 Feb 2026. The record gives the status Ongoing.

FDA enforcement report The 2 product records

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.

Distribution

In the words of FDA.

US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA

Recalling firm

Encore Medical, LP, Austin, TX.

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

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 98177: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1233-2026	EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705	19	Class II	Ongoing	11 Feb 2026
Z-1234-2026	EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C	49	Class II	Ongoing	11 Feb 2026

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.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

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

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2026: 572
Share of these events in Class II: 87%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 61

Other events of the firm

Other FDA enforcement events of 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
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
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 sur	Device	Class II	1

Encore Medical, LP: all 61 events

Official channels

FDA enforcement report Z-1233-2026The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 98177. https://recallregister.com/fda/ii/98177/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CA
What quantity of product is in FDA event 98177?: The event has 2 product records. The first record gives this quantity: 19
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2026 have the same class?: 87% of the 572 device events that started in 2026 are in Class II.