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Catalog Number 7601-90001 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/29/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A non-conformance was initiated to investigate the root cause associated with this failure mode.The resulting investigation identified a manufacturing nonconformance specific to lot ktgg, caused by excess thread locker being applied at the distal end of this lot of instruments during manufacture.Stryker has initiated a voluntary recall on 15-oct-2020 and an urgent medical device recall letter was sent to the affected customers, notifying them of the product issue and associated risks.
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Event Description
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During device inspection, it was noted that a yukon anti-torque alignment tube was out of specification.When tested, the final tightening shaft would not properly mate with the anti-torque tube.
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Search Alerts/Recalls
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