FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.
- Recall number
- Z-1496-2014
- Recalling firm
- Zimmer, Inc.
- Product
- TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.
- Status
- Terminated
- Initiated
- 2014-04-01
- Posted
- 2014-04-24
- Terminated
- 2014-09-11
- Reason
- The shell was missing the locking ring.
- Root cause
- Nonconforming Material/Component
- 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: 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.
- Quantity
- 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.
- Lot, serial or model codes
- 00-6202-060-22; lot 62490588
- 510(k) numbers
- ["K021891"]
- PMA numbers
- not on file
- Product code
- LPH
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28