FDA Device recall Z-0771-2013
Trilogy F/M Acetabular Shell with Uni-Hole
- FDA Device
- Class II
- terminated
- Published 2013-02-13
On 2013-02-13 the FDA classified a Class II recall of Trilogy F/M Acetabular Shell with Uni-Hole by Zimmer, citing 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 10/31/201….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0771-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-14 |
| Published | 2013-02-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
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
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.
Identifiers
| code_info | 61282267 61633887 61260645 61237937 61500763 61397941 61584769 61199849 61429445 61412089 00369745 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0771-2013%22
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