Knee tibial inserts recalled over a possible packaging discrepancy
Encore Medical is recalling 19 EMPOWR 3D Knee Tibial Inserts because several acetabular system and knee insert devices may have a packaging discrepancy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the packaging discrepancy may cause surgical delay to exchange devices or revision surgery, and no injuries are reported.
Plain-English summary
The EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF 342-14-705, is being recalled by Encore Medical, LP.
The record states a 942-01-40G acetabular system package was found to contain a 942-01-36H acetabular system, and that 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.
The record lists 19 units under UDI-DI 00888912167529, lot 139T1075A, expiration 03-12-2026. Distribution was to Texas, Iowa, Michigan, Mississippi, Massachusetts, Rhode Island, New Jersey, Pennsylvania, New York, Missouri, Oklahoma, Puerto Rico, Alabama and California. The FDA has classified the action as Class II.
A package holding a different implant than its label states can lead to surgical delay or revision surgery. The enforcement record reports no injuries. Facilities should quarantine affected stock and follow Encore Medical's instructions.
The recalled product
- Product
- EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
- Manufacturer
- Encore Medical, LP
- Affected units
- 19
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 00888912167529. Lot: 139T1075A. Expiration: 03-12-2026
Distribution
Part of a larger recall action
This product is one of 2 recalled by Encore Medical, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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