TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip im
FDA device recall Z-1496-2014 · posted 2014-04-24 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- The shell was missing the locking ring.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 17 units
- Distribution
- 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.
- Date initiated
- 2014-04-01
- Date posted
- 2014-04-24
- Date terminated
- 2014-09-11
- Location
- Warsaw, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM (K021891) | Zimmer, Inc. | 2002-09-05 |