The Recall Desk
ModerateFDA (Devices)·Z-0822-2017·Announced 2016-12-28

Stanmore Implants Recalls Punctured Femoral Shaft Components

Stanmore Implants Worldwide Ltd. is recalling 11 femoral shaft components due to punctured packaging reported by customers.

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. 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.
Category
Medical Device — Orthopedic Implants
Hazard
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

Distributed nationwide across the United States.

The notice also names 11 states specifically:

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 →

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