FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
- Recall number
- Z-0386-2013
- Recalling firm
- Zimmer, Inc.
- Product
- Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
- Status
- Terminated
- Initiated
- 2012-08-27
- Posted
- 2012-11-20
- Terminated
- 2013-08-27
- Reason
- Trilogy Longevity Constrained Liner devices were packaged in incorrect cartons. The product is packaged in the incorrect carton. Product labels and patient labels are correct, matching the product inside the carton.
- Root cause
- Labeling Change Control
- Action
- Zimmer contacted their customer beginning the week of August 27, 2012, via telephone. Zimmer informed the customer the reason of the recall. The customer was instructed to quarantine and return the device to Zimmer Product Service, 1777 W. Center St. Warsaw, IN 46580. The customer was asked to provide information if the product was further distributed. For further questions please call 574-372-4316.
- Quantity
- 1
- Distribution
- USA (nationwide) including the states of Ohio, Carolinas and New England.
- Lot, serial or model codes
- Item 00-6334-062-36, Lot 62023769
- 510(k) numbers
- ["K071718"]
- PMA numbers
- not on file
- Product code
- KWZ
- 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