Stanmore Implants Worldwide Ltd.: Medical Device Recall in 2016 - (Recall #: Z-0823-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone

Product Classification:

Class II

Date Initiated: December 7, 2016

Date Posted: December 28, 2016

Recall Number: Z-0823-2017

Event ID: 75892

Reason for Recall:

The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.

Status: Terminated

Product Quantity: 15 units

Code Information:

B10635, B11820, B12776, B10636, B10638, B9866

Distribution Pattern:

Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA

Voluntary or Mandated:

Voluntary: Firm initiated