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Recall Observatory FDA recall evidence

Device product

6376 M-1 Cot Fastener, catalog no. 6376000000

Z-1598-2018

March 09, 2018

Class II

Product summary

Firm
Stryker Medical Division of Stryker Corporation
Event
Event 79817
Status
Terminated
Classification
Class II
Quantity
59
Official record key
device-enforcement:Z-1598-2018

Official wording

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

Code information: Serial No. 170740300 170740301 170740302 170740303 170740304 170740305 170740306 170740307 170740308 170740309 170740310 170740311 170740312 170740313 170740314 170740315 170740316 170740317 170740318 170740319 170740320 170740321 170740322 170740323 170740324 170740325 170740326 170740327 170740328 170740329 170740330 170740331 170740332 170740333 170740334 170740335 170740336 170740337 170740338 170740339 170740340 170740341 170740342 170740343 170740344 170740345 170740346 170740347 170740348 170740349 170740350 170740351 170740352 170740353 170740354 170740355 170740356 170740357 170740358

Distribution pattern: Product distributed to the Netherlands

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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