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
FDA Recall Z-1845-2021 · Posted None
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Recalling FirmDePuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeJDI
Date Initiated2021-05-07
Date Terminated2023-03-09
Product Quantity50 units
Reason for Recall
Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
Firm 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 business response form (see page 3 of this notice) to [email protected]
4. Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the project subject to this recall).
5. If any of the subject product has been forwarded to another facility, contact that facility and provide them with this notice.
6. Post a copy of this notice in a visible area for awareness and keep a copy for your records.
Root Cause
Employee error
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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