Acetabular liners recalled over packages containing the wrong component
Encore Medical is recalling 49 EMPOWR acetabular system liners after a package labeled 942-01-40G was found to contain a 942-01-36H liner.
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 Acetabular System, covering the Liner, 10 degree Hooded, HXe+, in sizes 36H (REF 942-01-36H), 36J (REF 942-01-36J), 40G (REF 942-01-40G) and 32C (REF 942-01-32C), 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 49 units, with REF, UDI-DI, lot numbers and expiration dates recorded in the enforcement record. 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 size 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 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
- Affected units
- 49
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
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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