CLASS II Device recall · Reported 9 May 2018 · FDA Enforcement Report

6381 M-1 Cot Fastener recalled by Stryker Medical Division of

Stryker Medical Division of Stryker is recalling 6381 M-1 Cot Fastener. The recall was initiated on 9 Mar 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial No. 170740538 170740539 170740540

Quantity recalled3

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1599-2018
FDA event ID: 79817
Recalling firm: Stryker Medical Division of Stryker, Portage, MI
Classification: Class II
Status: Terminated
Recall initiated: 9 Mar 2018
FDA classified: 2 May 2018
Reported: 9 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

9 Mar 2018	Recall initiated by company
2 May 2018	Classified by FDA	+54 days
9 May 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.

Product as listed by the FDA

6381 M-1 Cot Fastener, catalog no. 6381000000

Where it was distributed

Product distributed to the Netherlands

Questions about this recall

Is 6381 M-1 Cot Fastener recalled?

Yes. Stryker Medical Division of Stryker recalled 6381 M-1 Cot Fastener on 9 Mar 2018. The recall is Class II and its status is Terminated. Recall number Z-1599-2018.

Why was it recalled?

The Operations Manual and Maintenance Manual are missing various warnings and contain incorrect information.

Which lots are affected?

Serial No. 170740538 170740539 170740540

Where was it sold?

Product distributed to the Netherlands

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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