CLASS II Device recall · Reported 28 Nov 2012 · FDA Enforcement Report
The Trilogy Acetabular System Shell with Cluster Holes Porous O.D recalled
Zimmer is recalling The Trilogy Acetabular System Shell with Cluster Holes Porous O.D, distributed nationwide in the US. The recall was initiated on 20 Sep 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-0416-2013
- FDA event ID
- 63541
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Sep 2012
- FDA classified
- 21 Nov 2012
- Reported
- 28 Nov 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 20 Sep 2012 | Recall initiated by company | |
| 21 Nov 2012 | Classified by FDA | +62 days |
| 28 Nov 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Zimmer Trilogy¿ Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Zimmer received one complaint in which no injury was reported.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused Hip, fracture of the pelvis, and diastrophic variant. The shells with screw holes permit the use of titanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient.
Where it was distributed
Worldwide Distribution--USA (nationwide) including the states of AL, CA, CT, KS, MA, MD, MN, MO, NY, SD, TX and WI and the countries of Bulgaria,Canada, Germany, Italy, Netherlands, Russian Fed, Sweden and UK
Nationwide AlabamaCaliforniaConnecticutKansasMassachusettsMarylandMinnesotaMissouriNew YorkSouth DakotaTexasWisconsin
Questions about this recall
Is The Trilogy Acetabular System Shell with Cluster Holes Porous O.D recalled?
Yes. Zimmer recalled The Trilogy Acetabular System Shell with Cluster Holes Porous O.D on 20 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-0416-2013.
Why was it recalled?
Zimmer Trilogy¿ Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Zimmer received one complaint in which no injury was reported.
Which lots are affected?
REF 6200-056-22, lot 62010615
Where was it sold?
Worldwide Distribution--USA (nationwide) including the states of AL, CA, CT, KS, MA, MD, MN, MO, NY, SD, TX and WI and the countries of Bulgaria,Canada, Germany, Italy, Netherlands, Russian Fed, Sweden and UK
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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