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Terminated

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

FDA Recall Z-1496-2014 · Posted 2014-04-24

Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeLPH
Date Initiated2014-04-01
Date Terminated2014-09-11
Product Quantity17 units

Reason for Recall

The shell was missing the locking ring.

Firm Action

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: [email protected]; 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.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K021891ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEMZimmer, Inc. · 2002-09-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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