Encore Medical Recalls EMPOWR PS Knee Inserts Due to Packaging Error
Encore Medical is recalling 46 EMPOWR PS Knee Inserts because one unit was packaged with the wrong implant. The recall covers US nationwide distribution.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific hazard is a packaging error involving the wrong implant reference number. There are no reported injuries or illnesses, and the risk is primarily related to potential incorrect surgical implantation rather than a direct toxic or structural failure of the material itself.
Plain-English summary
Encore Medical, Lp is recalling 46 units of EMPOWR PS KNEE(TM) e+ inserts, reference 343-19-707, size 7, 19mm. The recall is due to a packaging error where an implant labeled as 343-13-708 was packaged with the 343-19-707 implant.
The affected units are sterile, grey, and manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with alpha-tocopherol. The distribution pattern for these units was US Nationwide Distribution.
Healthcare providers and patients should check their inventory and records for Lot Number 055U1003. If the affected product is found, it should be quarantined and returned to Encore Medical, Lp according to their instructions.
The recalled product
- Product
- EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to…
- Manufacturer
- Encore Medical, Lp
- Affected units
- 46
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)
- Lot Number 055U1003
Distribution
Distributed nationwide across the United States.
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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