Device product
DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
Z-1845-2021
Product summary
- Event
- Event 87975
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-1845-2021
Official wording
Reason: Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
Code information: Lot: D20111130 GTIN: 10603295033172
Distribution pattern: Domestic: CA, CT, FL, GA, IA, IN, LA, ME, MN, MO, MT, NC, NE, NY, OH, OK, OR, PA, SC, TN, WI. Foreign: Bermuda
Derived failure modes
-
Unknown
Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.