Trilogy II Constrained Liner recallZ-0386-2013 · Zimmer, Inc. · initiated Aug 27, 2012
Class II Terminated All recalls posted in November 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-0386-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 27, 2012
- Posted by the FDA
- Nov 20, 2012
- Recalling firm
- Zimmer, Inc.
- Quantity
- 1
- Product code
- KWZ
- FDA submissions
- K071718
- Distribution
- USA (nationwide) including the states of Ohio, Carolinas and New England.
Product description
Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
Code information (models, lots, serial numbers)
Item 00-6334-062-36, Lot 62023769
Other devices under the same FDA submission
3 devices cleared under K071718 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Trilogy® Longevity® 00-6334-050-28Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED11 reports
- Trilogy® Longevity® 00-6334-050-28Zimmer, Inc. · Prosthesis, hip, constrained, cemented or uncemented, metal/polymer2 reports
- Trilogy® Longevity® 00-6334-058-32Zimmer, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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