—#126336

Product

TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K021891
Affected lot / code info: 00-6202-060-22; lot 62490588

Why it was recalled

The shell was missing the locking ring.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The firm, Zimmer, sent an "URGENT MEDICAL DEVICE RECALL-LOT SPECIFIC" notification dated April 2014 to their consignees. The notification included product description, product issue, health risks, and consignee responsibilities (including directions on how to return the affected product). The consignees were instructed to locate all products from lot 62490588 and quarantine them immediately; carry out a physical count of all affected product; complete and return the Inventory Return Certification Form via email to: corporatequality.postmarket@zimmer.com; return the recalled product, and notify Zimmer of any hospitals that you have further distributed the affected product and of surgeons that have implanted the product. Consignees with questions pertaining to the recall are directed to call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern: Worldwide Distribution: US (nationwide) in states of: US: GA, WI, NJ, CA, NY, NC, PA, FL, CT, ME, TX, and IL; and countries of: Australia and Canada.

Timeline

Recall initiated: 2014-04-01
Posted by FDA: 2014-04-24
Terminated: 2014-09-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126336. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.