Ultra-Drive Irrigation Tubing Assembly — Class II medical device recall Z-1963-2019
Terminated recall by Zimmer Biomet, Inc., reported 2019-07-24, distributed nationwide. The products do not have sufficient data to support the labeled shelf life of 10 years.
| Recall number | Z-1963-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2019-06-04 |
| Classified | 2019-07-12 |
| Reported by FDA | 2019-07-24 |
| Terminated | 2021-07-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CL, CN, HK, IN, JP, MY, NL, TW |
| Quantity | 8,478 total |
| Reason classes | labeling |
| Lot numbers | 209586, 210002, 210488, 210566, 210848, 210867, 210972, 211172, 211237, 211325, 212076, 212488, 212622, 212928, 212966, 214005, 214051, 214118, 214255, 214499, 214546, 214669, 214822, 214995, 215048, 215329, 215445, 215524, 215623, 216489, 216611, 217370, 217556, 217761, 217767, 218667, 219305, 219661, 219913, 220935 |
Product
Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
Reason for recall
The products do not have sufficient data to support the labeled shelf life of 10 years.
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-1963-2019. 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.