FDA Enforcement
Class II
Terminated
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
Recall: Z-1845-2021
·
Reported June 16, 2021
Enforcement
- Recall Number
- Z-1845-2021
- Event ID
- 87975
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- DePuy Orthopaedics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 16, 2021
- Initiation Date
- May 7, 2021
- Classification Date
- June 10, 2021
- Termination Date
- March 9, 2023
- Address
- 700 Orthopaedic Dr, N/A, Warsaw, IN, 46582-3994, United States
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
Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
Code Info
Lot: D20111130 GTIN: 10603295033172
Distribution
Domestic: CA, CT, FL, GA, IA, IN, LA, ME, MN, MO, MT, NC, NE, NY, OH, OK, OR, PA, SC, TN, WI. Foreign: Bermuda
Quantity
50 units