Trabecular Metal Tibial Impactor Replacement Pads — Class II medical device recall Z-0424-2015
Terminated recall by Zimmer, Inc., reported 2014-12-03, distributed nationwide. To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impacto
| Recall number | Z-0424-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-10-14 |
| Classified | 2014-11-23 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2015-06-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CN, DE, DK, ES, FI, FR, GB, GR, IS, IT, JP, MT, NL, NO, PL, SA, SE, SK, ZA |
| Quantity | 4,961 units |
| Reason classes | device malfunction |
| Model numbers | 00-5953-056-06 |
Product
Trabecular Metal Tibial Impactor Replacement Pads. Product Usage: TM Tibial Impactor pads are used in conjunction with the TM Tibial Impactor to impact the tibial tray onto the tibia.
Reason for recall
To provide clarifying instructions relating to the assembly/disassembly of the Trabecular Metal Tibial Impactor with/from TM tibial Impactor Pads due to complaints regarding Tibal Impactor pad fracture.
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-0424-2015. 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.