Stanmore Implants Recalls Punctured Femoral Stem Components
Stanmore Implants Worldwide Ltd. is recalling 15 femoral stem components because customer inquiries reported that the device stem punctured the packaging pouch.
What this means for you
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, which corresponds to a moderate severity score. The hazard involves a packaging defect (punctured pouch) rather than a direct structural failure of the implant itself, and no injuries or illnesses are reported in the source text.
Plain-English summary
Stanmore Implants Worldwide Ltd. is recalling 15 units of Femoral Integral Shaft & Stem components (HA Coated) due to a packaging defect. The recalling 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 products are components intended for the replacement of diseased or deficient bone around the knee joint, distal femur, proximal femur, or total femur bone. The specific units involved are identified by codes B10635, B11820, B12776, B10636, B10638, and B9866.
These products were distributed nationwide to Ohio, Nebraska, Florida, Louisiana, New York, Texas, Mississippi, Maryland, Connecticut, Alabama, and Pennsylvania. Consumers and healthcare providers should stop using the affected units and contact the recalling firm for further instructions.
The recalled product
- Product
- Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated The product is a component is a systems that is intended for the replacement if dise
- 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 (6)
- B10635
- B11820
- B12776
- B10636
- B10638
- B9866
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 Shaft 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 →- HighMD Wipe Outz Numbing Tattoo Wipes Recalled for Child Poisoning Risk
CPSC · 2026-08-27
- SevereDermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12