Stanmore Implants Recalls Tibial Components Due to Packaging Puncture
Stanmore Implants Worldwide Ltd. is recalling 51 tibial components because the device stem may have punctured the sterile packaging.
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, and the hazard involves a packaging defect that compromises sterility. No illnesses or injuries are reported in the source text, and the defect is a packaging issue rather than a structural failure of the implant itself.
Plain-English summary
Stanmore Implants Worldwide Ltd. is recalling 51 units of Tibial Component Metal Cased Small Long, Small Short, Std Long, and Std Short. These medical devices are intended for the replacement of diseased or deficient bone around the knee joint, distal femur, proximal femur, or total femur bone.
The recall was initiated after the firm received five customer inquiries reporting that at least one pouch of the double pouch packaging configuration had been punctured by the tip of the device's stem. This defect compromises the sterile barrier of the packaging.
The affected units were distributed nationwide to Ohio, Nebraska, Florida, Louisiana, New York, Texas, Mississippi, Maryland, Connecticut, Alabama, and Pennsylvania. Specific lot codes for the recalled units include A10337, A11525, A7823, A9990, A11289, A11979, A12134, A7186, A8679, A9743, A10344, A10629, A10791, A10348a, A11198, A11557, A11895, A12090, A12129, A12220, A12223, and A12229. Healthcare providers and consumers should check their inventory for these specific codes and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the…
- Manufacturer
- Stanmore Implants Worldwide Ltd.
- Affected units
- 51
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 (20)
- A10337
- A11525
- A7823
- A9990
- A11289
- A11979
- A12134
- A7186
- A8679
- A9743
- A10344
- A10629
- A10791
- A10348a
- A11198
- A11557
- A11895
- A12090
- A12129
- A12220
Distribution
Part of a larger recall action
This product is one of 5 recalled by Stanmore Implants Worldwide Ltd. 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 5 products in this recall →Related recalls
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