Stanmore Implants Recalls DF Coated Integral Shaft and Stem Components
Stanmore Implants Worldwide Ltd. is recalling 15 units of DF Coated Integral Shaft & Stem components due to packaging punctures reported by customers.
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 defect (punctured pouch) without reporting any patient injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stanmore Implants Worldwide Ltd. is recalling 15 units of DF Coated Integral Shaft & Stem components. The affected products are intended for the replacement of diseased or deficient bone around the knee joint, distal femur, proximal femur, or total femur bone. The specific sizes involved are 15x30x38, 15x36x44, 30x30x38, and 30x36x44.
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 products were distributed nationwide to Ohio, Nebraska, Florida, Louisiana, New York, Texas, Mississippi, Maryland, Connecticut, Alabama, and Pennsylvania.
Healthcare providers and consumers should check their inventory for the specific lot codes B10586, B11126, B9875, B9946, B10751, B11513, B9874, B10602, and B9876. If these products are found, they should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 The product is a component is a systems that is intended for the replacement if diseased or…
- Manufacturer
- Stanmore Implants Worldwide Ltd.
- Affected units
- 15
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 (9)
- B10586
- B11126
- B9875
- B9946
- B10751
- B11513
- B9874
- B10602
- B9876
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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