Data Foundry

Medical device recalls 2018

6376 M-1 Cot Fastener — Class II medical device recall Z-1598-2018

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 numberZ-1598-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmStryker Medical Division of Stryker Corporation, Portage, MI, United States
Recall initiated2018-03-09
Classified2018-05-02
Reported by FDA2018-05-09
Terminated2019-04-09
Countries outside the USNL
Quantity59
Serial numbers170740300, 170740301, 170740302, 170740303, 170740304, 170740305, 170740306, 170740307, 170740308, 170740309, 170740310, 170740311, 170740312, 170740313, 170740314, 170740315, 170740316, 170740317, 170740318, 170740319, 170740320, 170740321, 170740322, 170740323, 170740324 and 34 more
Model numbers6376000000

Product

6376 M-1 Cot Fastener, catalog no. 6376000000

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-1598-2018. 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.