FDA Device recall Z-0338-2021
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-…
- FDA Device
- Class II
- terminated
- Published 2020-11-11
On 2020-11-11 the FDA classified a Class II recall of ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-… by Zimmer Biomet, citing 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 pote….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0338-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-24 |
| Published | 2020-11-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-26
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.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Other recalls by Zimmer Biomet
- Spinal Rod Cutter, Item number 00392500200
FDA Device · Class II · 2020-12-30 · Zimmer Biomet - Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
FDA Device · Class II · 2020-12-23 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 55 mm Item Number: 00-8065-552-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, Neutral, O.D. Cup with Spacers, 51 mm Item Number: 00-8065-548-…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet - ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm Number: 0…
FDA Device · Class II · 2020-11-11 · Zimmer Biomet
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0338-2021%22
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