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Recall Observatory FDA recall evidence

Device product

RSP Impaction Fixture

Z-1413-2017

February 09, 2017

Class II

Product summary

Firm
Encore Medical, Lp
Event
Event 76456
Status
Terminated
Classification
Class II
Quantity
626 units
Official record key
device-enforcement:Z-1413-2017

Official wording

Reason: During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.

Code information: 109931L01, 109931L02, 115670L15, 115670L16, 128092L08, 128092L09, 137917L16, 167829L06, 52258L01, 52258L01A, 67428L01, 76386L01, 76386L02, 81722L01, 81722L02

Distribution pattern: US, South Korea, Australia, Canada, United Kingdom/Ireland, Germany

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    During the Turon assembly, the impaction forces caused the polymer, black acetal copolymer from the Impaction Fixture to wear off on the lateral surface of the Humeral Stem titanium plasma spray coating.