00-4309-028-01 — Class II medical device recall Z-2213-2012
Terminated recall by Zimmer, Inc., reported 2012-08-22, distributed nationwide. Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of align
| Recall number | Z-2213-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2012-07-18 |
| Classified | 2012-08-16 |
| Reported by FDA | 2012-08-22 |
| Terminated | 2014-04-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, DE, DK, ES, FI, FR, GB, IT, NL, SE |
| Quantity | 252 |
| Reason classes | device malfunction |
| Lot numbers | 60529860, 60574377, 60589079, 60605856, 60616574, 60684774, 60739623, 60842967, 60896979, 60936815, 61019785, 61051017 |
| Model numbers | 00-4309-028-01 |
Product
00-4309-028-01 - Trabecular Metal Reverse Shoulder Liner 40mm 65¿ Neck Angle Per surgical technique 97-4309-003-00 Revision 4: "Complete Poly Liner insertion by snapping the appropriate 60¿ (Standard) or 65¿ (Retentive) Poly Liner Impactor to the Poly Liner Impactor Handle. Then, place the Poly Liner Impactor on the Poly Liner articular surface and forcefully strike the Poly Liner Handle with a mallet."
Reason for recall
Lot specific Trabecular Metal (TM) Reverse Shoulder Liner Impactors are being recalled due to reports of alignment peg fractures. All lots of TM Reverse Shoulder Liner Impactors manufactured from 455 stainless steel are being retrieved, as all reported fractured instruments were manufactured with this material. The TM Reverse Shoulder Liner Impactor units that were manufactured with 13-8 stain
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-2213-2012. 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.