Hip Stem Implants Subject to Product Mix Recall
Howmedica Osteonics has recalled EXETER V40 hip stem implants due to packaging errors where boxes may contain the wrong model or lot number. Affected units should be verified with surgical providers.
What this means for you
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 an FDA Class II recall of orthopedic implants with a product mix where packages may contain incorrect models. Although the hazard poses real risk of harm from size mismatch, no injuries or hospitalizations have been reported, limiting the score to High rather than Severe.
Plain-English summary
Howmedica Osteonics Corp. has recalled two EXETER V40 hip stem implant models due to a product mix issue. Specifically, packages labeled as Catalog Number 0580-1-442 (44MM, Lot A00976) may contain Catalog Number 0580-1-352 (37.5MM, Lot G8754849), and vice versa. Patient labels associated with these implants may also be incorrect.
The affected devices were distributed to the United Kingdom. A total of 55 units were involved in this recall, all located outside the United States.
Patients who received hip implants during the relevant period should contact their healthcare provider or surgeon to verify they received the correct implant model and size. Healthcare providers should check their records and contact Howmedica Osteonics if they believe they implanted affected units.
The recalled product
- Product
- 1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- product-mix
- mis-labeling
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 (6)
- 1. Model/Catalog Number: 0580-1-442
- UDI-DI: 04546540153319
- Lot Number: A00976
- 2. Model/Catalog Number: 0580-1-352
- UDI-DI: 04546540153241
- Lot Number: G8754849
Distribution
Distribution scope not specified by the agency.
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