Trilogy F/M Acetabular Shell with Uni-Hole — Class II medical device recall Z-0771-2013
Terminated recall by Zimmer, Inc., reported 2013-02-13, distributed nationwide. Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size speci
| Recall number | Z-0771-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2012-09-14 |
| Classified | 2013-02-04 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2014-06-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, CL, CO, DE, DK, ES, FR, GB, GR, HU, IE, IN, IT, JP, NL, NZ, PE, PL, SE, UA, ZA |
| Quantity | 275,952 units |
Product
Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Reason for recall
Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0771-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.