Recall Z-1845-2021 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
DePuy Orthopaedics, Inc.
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
| Date | May 7, 2021 |
| Status | Terminated |
| Reason | Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product. |
| Root cause | Employee error |
| Action | On May 12, 2021, DePuy Synthes issued an Urgent Medical Device Removal notice to customers via letter notifying them that DePuy Synthes has determined that individual units of ARTICUL/EZETM Femoral Heads were distributed with the incorrect part number and size etched on the product. Please take the Following Steps: 1. Examine your inventory immediately to determine if you have the lot subject to this recall and quarantine the product. 2. Contact your DePuy Synthes Sales Consultant to coordinate the return of any products from the affected lot. 3. Complete, sign and return the attached busine |
| Quantity | 50 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K843909 | TITANIUM HIP 1019 Depuy, Inc., Nov 15, 1984 |