Stanmore Implants Worldwide Ltd.: Medical Device Recall in 2016 - (Recall #: Z-0821-2017)

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:

Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short 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-0821-2017

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: 51 units

Code Information:

A10337, A11525, A7823, A9990, A11289, A11979, A12134, A7186, A8679, A9743, A10344, A10629, A10791, A10348a, A11198, A11557, A11895, A12090, A12129, A12220, A12223, A12229

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated