Z-1845-2021 Class II Terminated
FDA device recall Z-1845-2021 was initiated by DePuy Orthopaedics, Inc. on May 7, 2021 and is designated Class II. Reason for recall: Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product. The recall status is terminated (terminated March 9, 2023). Affected quantity: 50 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 16, 2021
- Initiation Date
- May 7, 2021
- Termination Date
- March 9, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 units
Product Description
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
Reason for Recall
Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
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
Code Information
Lot: D20111130 GTIN: 10603295033172