EMPOWR hip acetabular implant packaging incorrectly contains knee implant component
Encore Medical recalled 20 units of EMPOWR Acetabular System hip implant liners after knee implant components were mistakenly placed in hip surgery packages. Surgeons using the wrong implant could receive an anatomically incompatible component.
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: This is a risk-of-harm product where injury has not yet been reported. Using an anatomically incorrect hip implant during surgery could result in serious patient complications. However, no actual injuries or incidents have been documented in the source material.
Plain-English summary
Encore Medical recalled the EMPOWR Acetabular System Liner (Reference 942-01-40H, Lot 629Z1114) due to a critical packaging error. Twenty units were affected when knee and acetabular (hip) system components were swapped within inner packaging before products were sealed.
During the manufacturing process, knee implant parts were mistakenly placed in packages designated for hip surgery. Because hip and knee implants have different anatomical requirements, surgeons receiving these packages might unknowingly attempt to use an incorrect implant component during surgery.
The recalled implants were distributed nationwide to healthcare facilities in Florida, California, Indiana, Hawaii, Louisiana, Minnesota, Arizona, Texas, New Jersey, Pennsylvania, Kansas, Tennessee, Puerto Rico, South Carolina, and Washington. Healthcare providers who received products from Lot 629Z1114 should immediately verify the correct components are present before any surgical use and contact Encore Medical with questions.
The recalled product
- Product
- EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H
- Manufacturer
- Encore Medical, LP
- Affected units
- 20
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)
- UDI-DI: 00190446309833
- Lot: 629Z1114
- Expiration: March 30
- 2028
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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