Z-0394-2021 Class II Terminated
FDA device recall Z-0394-2021 was initiated by Zimmer Biomet, Inc. on Sep 24, 2020 and is designated Class II. 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… The recall status is terminated (terminated May 20, 2022). Affected quantity: 412 units total.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 11, 2020
- Initiation Date
- Sep 24, 2020
- Termination Date
- May 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 412 units total
Product Description
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 55 mm Number: 00-8065-952-32
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.
Distribution Pattern
US Nationwide
Code Information
All lots
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0394-2021
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026