EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Pending LLM rewrite. Source: FDA_DEVICE Z-1233-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
- Manufacturer
- Encore Medical, LP
- Category
- Medical Device — Devices
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
Distributed in 14 states:
- AL
- CA
- IA
- MA
- MI
- MO
- MS
- NJ
- NY
- OK
- PA
- PR
- RI
- TX
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