FDA Enforcement
Class II
Terminated
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-26
Recall: Z-0354-2021
·
Reported November 11, 2020
Enforcement
- Recall Number
- Z-0354-2021
- Event ID
- 86521
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zimmer Biomet, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 11, 2020
- Initiation Date
- September 24, 2020
- Classification Date
- November 2, 2020
- Termination Date
- May 20, 2022
- Address
- 1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States
Description
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 61 mm Number: 00-8065-558-26
Reason
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.
Code Info
All lots
Distribution
US Nationwide
Quantity
412 units total