Patella implant component recalled due to labeling error
Encore Medical has voluntarily recalled a patella implant component (REF 130-03-738) due to mislabeling. The recall involves 2 units distributed nationwide.
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: FDA Class II classification applied to a labeling error in a medical device with no reported adverse events. The recall is voluntary and initiated by the manufacturer, indicating a precautionary measure rather than identified patient harm.
Plain-English summary
Encore Medical, LP has initiated a voluntary recall of the REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm patella implant component due to mislabeling. The recall was initiated on October 5, 2023.
The affected device was distributed nationwide across Virginia, Tennessee, Minnesota, Indiana, Rhode Island, Maine, Texas, Louisiana, Alabama, Florida, and California. Two units are involved in the recall, with lot number 157N1556.
The FDA classified this recall as Class II. No adverse events have been reported in connection with this product.
The recalled product
- Product
- REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2
- Manufacturer
- Encore Medical, LP
- Hazard
- Affected units
- 2
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: (01)00888912108560/Lot Number(s): 157N1556
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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