Device product
RSP Standard HUMERAL SOCKET INSERT, 40 MM plus 4MM, HXe-Plus, Part No. 509-00-440
Z-3022-2020
Product summary
- 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
mislabeled