—#187571

Product

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 product code: JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K843909
Affected lot / code info: Lot: D20111130 GTIN: 10603295033172

Why it was recalled

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

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: DePuy Orthopaedics, Inc.
Address: 700 Orthopaedic Dr, Warsaw, Indiana 46582-3994

Distribution

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

Timeline

Recall initiated: 2021-05-07
Terminated: 2023-03-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187571. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.