Tritanium Posterior Lumbar — Class II medical device recall Z-0605-2019
Terminated recall by Howmedica Osteonics Corp., reported 2018-12-19, distributed nationwide. The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring i
| Recall number | Z-0605-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Allendale, NJ, United States |
| Recall initiated | 2018-11-28 |
| Classified | 2018-12-13 |
| Reported by FDA | 2018-12-19 |
| Terminated | 2020-05-28 |
| Distributed | Nationwide (US) |
| Quantity | 28,461 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07613327117943 |
| Model numbers | 48950066, 48950070, 48950076, 48950080, 48950086, 48950090, 48950092, 48950096, 48950100, 48950102, 48950106, 48950110, 48950112, 48950116, 48950120, 48950122, 48950126, 48950130, 48950132, 48950136, 48950140, 48950142, 48950146, 48951070, 48951076 and 83 more |
Product
Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
Reason for recall
The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.
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-0605-2019. 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.