6381 M-1 Cot Fastener — Class II medical device recall Z-1599-2018
Terminated recall by Stryker Medical Division of Stryker Corporation, reported 2018-05-09. The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.
| Recall number | Z-1599-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Medical Division of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2018-03-09 |
| Classified | 2018-05-02 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2019-04-09 |
| Countries outside the US | NL |
| Quantity | 3 |
| Serial numbers | 170740538, 170740539, 170740540 |
| Model numbers | 6381000000 |
Product
6381 M-1 Cot Fastener, catalog no. 6381000000
Reason for recall
The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.
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-1599-2018. 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.