Stanmore Tibial Component Fixed Hinge Recall Due to Pouch Puncture
Stanmore Implants Worldwide Ltd. is recalling 13 units of Tibial Component Fixed Hinge Small Long and Short due to punctured 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 packaging integrity (puncture) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stanmore Implants Worldwide Ltd. is recalling 13 units of Tibial Component Fixed Hinge Small Long and Tibial Component Fixed Hinge Small 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. The affected units were distributed nationwide to Ohio, Nebraska, Florida, Louisiana, New York, Texas, Mississippi, Maryland, Connecticut, Alabama, and Pennsylvania.
Healthcare providers and patients should stop using the affected devices and contact the manufacturer for further instructions. The specific lot codes associated with this recall are A11290, A10107, A11828, A10610, A10765, A11439, and A11922.
The recalled product
- Product
- Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
- Manufacturer
- Stanmore Implants Worldwide Ltd.
- Hazard
- Affected units
- 13
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 (7)
- A11290
- A10107
- A11828
- A10610
- A10765
- A11439
- A11922
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.
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