Zimmer Biomet, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0340-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-32

Product Classification:

Class II

Date Initiated: September 24, 2020

Date Posted: November 11, 2020

Recall Number: Z-0340-2021

Event ID: 86521

Reason for Recall:

Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.

Status: Terminated

Product Quantity: 412 units total

Code Information:

All lots

Distribution Pattern:

US Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated