CLASS II Device recall · Reported 28 Nov 2012 · FDA Enforcement Report
Trilogy II Constrained Liner The Trilogy Longevity recalled by Zimmer
Zimmer is recalling Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the, distributed nationwide in the US. The recall was initiated on 27 Aug 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0386-2013
- FDA event ID
- 63126
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Aug 2012
- FDA classified
- 20 Nov 2012
- Reported
- 28 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 27 Aug 2012 | Recall initiated by company | |
| 20 Nov 2012 | Classified by FDA | +85 days |
| 28 Nov 2012 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the articular surface for a femoral head in total hip arthroplasty.
Where it was distributed
USA (nationwide) including the states of Ohio, Carolinas and New England.
Questions about this recall
Is Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the recalled?
Yes. Zimmer recalled Trilogy II Constrained Liner The Trilogy Longevity Constrained Liner serves as the on 27 Aug 2012. The recall is Class II and its status is Terminated. Recall number Z-0386-2013.
Why was it 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.
Which lots are affected?
Item 00-6334-062-36, Lot 62023769
Where was it sold?
USA (nationwide) including the states of Ohio, Carolinas and New England.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |