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Recall Observatory FDA recall evidence

Device product

RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440

Z-3022-2020

August 07, 2020

Class II

Product summary

Firm
Encore Medical, LP
Event
Event 86317
Status
Ongoing
Classification
Class II
Quantity
37 units
Official record key
device-enforcement:Z-3022-2020

Official wording

Reason: Product may be mislabeled with the size etched onto products differing from the size information shown on patient sticker labels. Risks associated with this issue may include the Surgeon implanting the incorrect size; significant physical impairment, discomfort and/or disruption of treatment of underlying condition; and the patient experiencing dislocation resulting in revision surgery.

Code information: Part 509-00-440, Lot Numbers 387P1042A and 387P1045A, UDI: 00888912144599

Distribution pattern: Distributed in the U.S. to: VA, MN, IN, RI, PA, NY, WA, KS, OK, FL, GA and CA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled