Stanmore Implants Worldwide Ltd.: Medical Device Recall in 2016 - (Recall #: Z-0824-2017)

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:

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 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-0824-2017

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:

B10586, B11126, B9875, B9946, B10751, B11513, B9874, B10602, B9876

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated