Maximum Variable Pitch Compression Tray Base — Class II medical device recall Z-0734-2019
Terminated recall by Zimmer Biomet, Inc., reported 2019-01-23, distributed nationwide. There is a potential for silicone shedding during cleaning and sterilization.
| Recall number | Z-0734-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2018-11-28 |
| Classified | 2019-01-14 |
| Reported by FDA | 2019-01-23 |
| Terminated | 2020-05-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CL, NL |
| Quantity | 971 i |
| Lot numbers | 453392, 453918, 453919, 469917, 475577, 481064, 481065, 486820, 498695, 506818, 512868 |
Product
Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals
Reason for recall
There is a potential for silicone shedding during cleaning and sterilization.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0734-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.