Hip Liner Implants Mixed with Knee Inserts in Packaging
Encore Medical is recalling EMPOWR hip liner implants because boxes may contain knee inserts instead. This packaging error could delay surgeries. Four units affected in six US states.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II medical device recall involving a packaging error that creates risk of harm by making necessary implants unavailable when needed for surgery. No injuries or illnesses have been reported, meeting the rubric criterion for High (3): risk-of-harm products where injury has not yet been reported.
Plain-English summary
Encore Medical, LP is recalling EMPOWR Acetabular System hip liner implants (REF: 942-01-40H, Lot 629Z1085) due to a packaging error discovered during distribution.
Hip liner implant boxes may contain knee inserts, and knee insert boxes may contain hip liner implants. This mix-up means the correct implants may not be available when needed for scheduled surgical procedures, potentially causing delays in surgery.
The recalled implants were distributed nationwide to healthcare facilities in Florida, Indiana, Illinois, Kentucky, Arizona, and Texas. Four units are affected under UDI 00190446309833.
Healthcare facilities that received affected implants should verify package contents of their stock before use. If questions arise regarding implant sourcing or if surgery delays occur due to this mix-up, contact the healthcare provider or Encore Medical directly.
The recalled product
- Product
- EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
- Manufacturer
- Encore Medical, LP
- Affected units
- 4
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/Lot: 00190446309833/629Z1085
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.
See all 2 products in this recall →Related recalls
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