Recall Z-1845-2021

Reason for recall

Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.

FDA-determined cause: Employee error

Action taken

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 OneMD-Field-Actions@its.jnj.com 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.