Recall Z-1599-2018— Stryker Medical Division of Stryker Corporation
Class II · Terminated
Class II FDA medical device recall by Stryker Medical Division of Stryker Corporation, initiated 2018-03-09, terminated 2019-04-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 6381 M-1 Cot Fastener, catalog no. 6381000000. Reason: The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information..
- Recalling firm
- Stryker Medical Division of Stryker Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-09
- Terminated
- 2019-04-09
- Firm location
- Portage, MI, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.