[pending] EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hood
Pending LLM rewrite. Source: FDA_DEVICE Z-1234-2026.
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: Pending LLM scoring against the rubric.
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 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
- 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 (4)
- REF/UDI-DI/Lot(Expiration): 942-01-36H/00190446309789/624Z1032(03-15-2026)
- 942-01-36J/00190446309802/626Z1021(03-15-2026)
- 942-01-40G/00190446309826/628Z1034(03-15-2026)
- 942-01-32C/00190446309697/615Z1026(03-15-2026)
Distribution
Distributed in 14 states:
- AL
- CA
- IA
- MA
- MI
- MO
- MS
- NJ
- NY
- OK
- PA
- PR
- RI
- TX
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