Z-1599-2018 Class II Terminated

Recalled by Stryker Medical Division Of Stryker Corporation — Portage, MI

FDA device recall Z-1599-2018 was initiated by Stryker Medical Division Of Stryker Corporation on Mar 9, 2018 and is designated Class II. Reason for recall: The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information. The recall status is terminated (terminated Apr 9, 2019). Affected quantity: 3.

Recall Details

Product Type
Devices
Report Date
May 9, 2018
Initiation Date
Mar 9, 2018
Termination Date
Apr 9, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3

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.

Distribution Pattern

Product distributed to the Netherlands

Code Information

Serial No. 170740538 170740539 170740540

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1599-2018
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.