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Recall Observatory FDA recall evidence

Device product

GEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical

Z-1692-2013

May 30, 2013

Class II

Product summary

Firm
DeRoyal Industries Inc
Event
Event 65554
Status
Terminated
Classification
Class II
Quantity
87 units
Official record key
device-enforcement:Z-1692-2013

Official wording

Reason: DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization.

Code information: Serial Numbers: 25405311, 25405485, 25556398, 25866038, 25920479, 25969803, 26040887, 26092011, 26092089, 26109451, 26198457, 26262324, 26330892, 26394079, 26568438, 26637085, 26695568, 26938574, 26942371, 26946478, 27751648, 27860730, 27905871, 27915366

Distribution pattern: USA Nationwide Distribution in the state of PA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    DeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization.