Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0041-2018·Announced 2017-11-01

Encore Medical Recalls EMPOWR PS Knee Inserts Due to Packaging Error

Encore Medical is recalling 48 units of EMPOWR PS Knee inserts because one unit was packaged with the wrong implant reference number.

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 source text describes a packaging/labeling error without reporting any injuries, illnesses, or adverse health consequences, fitting the criteria for a moderate severity labeling error.

Plain-English summary

Encore Medical, Lp is recalling 48 units of EMPOWR PS KNEE(TM) e+ inserts, reference 343-13-708, size 8, 13mm, lot number 287U1004. The recall was initiated because it was reported that an implant labeled as 343-13-708 was packaged with implant 343-19-707.

The affected products are sterile, sky blue, posterior stabilized knee inserts made from ultra high molecular weight polyethylene infused with alpha-tocopherol. The distribution pattern for these units was US Nationwide Distribution.

Healthcare providers and facilities should stop using the affected lot and contact Encore Medical for instructions on returning the product. This recall addresses a packaging and labeling discrepancy rather than a defect in the implant material itself.

The recalled product

Product: EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, 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
Category: Medical Device — Orthopedic Implants
Hazard: mis-labeling
packaging-error
Affected units: 48

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 287U1004

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.

See all 2 products in this recall →

Same manufacturer · Encore Medical, Lp

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Same hazard · mis labeling