Stanmore Implants Recalls Punctured Femoral Shaft Components
Stanmore Implants Worldwide Ltd. is recalling 11 femoral shaft components due to punctured packaging 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. The hazard involves packaging integrity (punctured pouches) rather than a direct structural defect in the implant itself, and no injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stanmore Implants Worldwide Ltd. is recalling 11 units of femoral shaft components (lengths 120mm, 135mm, and 150mm). These components are part of a system 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 check their inventory and records for the following lot codes: B10191, B10443, B9920, B10561, B9921, and B9922. If these specific units are found, they should be removed from use and returned to the manufacturer or the appropriate regulatory authority.
The recalled product
- Product
- Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm 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.
- Affected units
- 11
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)
- B10191
- B10443
- B9920
- B10561
- B9921
- B9922
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
Same manufacturer · Stanmore Implants Worldwide Ltd.
See all →- HighStanmore JTS Distal Femoral Implant Recalled Due to Extension Failure
FDA (Devices) · 2017-09-13
- ModerateStanmore Implants Recalls Tibial Components Due to Packaging Puncture
FDA (Devices) · 2016-12-28
- ModerateStanmore Implants Recalls DF Coated Integral Shaft and Stem Components
FDA (Devices) · 2016-12-28
- ModerateStanmore Implants Recalls Punctured Femoral Stem Components
FDA (Devices) · 2016-12-28
- ModerateStanmore Tibial Component Fixed Hinge Recall Due to Pouch Puncture
FDA (Devices) · 2016-12-28
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- HighStanmore Distal Femoral Replacement Recalled for Incorrect Component
FDA (Devices) · 2016-05-18
- HighStanmore JTS Distal Femoral Implant Recalled Due to Extension Failure
FDA (Devices) · 2017-09-13
- HighStanmore METS SMILES Total Knee Replacement Recall for Fit Issues
FDA (Devices) · 2016-08-24
- HighBiomet Vanguard Knee Implant Components Recalled for Incorrect Labeling
FDA (Devices) · 2023-02-08
- LowBiomet Recalls Hip Components Due to Incorrect GTIN Labeling Codes
FDA (Devices) · 2015-06-17
- ModerateZimmer Biomet Recalls Vanguard Total Knee System Femoral Components Due to Labeling Errors
FDA (Devices) · 2017-02-08