FDA Enforcement
Class II
Terminated
6381 M-1 Cot Fastener, catalog no. 6381000000
Recall: Z-1599-2018
·
Reported May 9, 2018
Enforcement
- Recall Number
- Z-1599-2018
- Event ID
- 79817
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Medical Division of Stryker Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Other
- Report Date
- May 9, 2018
- Initiation Date
- March 9, 2018
- Classification Date
- May 2, 2018
- Termination Date
- April 9, 2019
- Address
- 3800 E Centre Ave, N/A, Portage, MI, 49002-5826, United States
Description
6381 M-1 Cot Fastener, catalog no. 6381000000
Reason
The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.
Code Info
Serial No. 170740538 170740539 170740540
Distribution
Product distributed to the Netherlands
Quantity
3