Product is distributed by Zimmer — Class II medical device recall Z-1115-2013
Terminated recall by Synvasive Technology Inc, reported 2013-04-24, distributed nationwide. Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) Th
| Recall number | Z-1115-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synvasive Technology Inc, El Dorado Hills, CA, United States |
| Recall initiated | 2013-04-02 |
| Classified | 2013-04-15 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2014-07-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CZ, DE, DK, ES, FI, FR, GB, IT, JP, NL, NO, PA, SE, TN |
| Quantity | 3,442 units |
| Reason classes | labeling |
Product
Product is distributed by Zimmer (Warsaw, Indiana)/Synvasive Technology, Inc. (El Dorado Hills, CA) & manufactured under Synvasive Technology, Inc. El Dorado Hills, CA Reciprocating saw blade: A sterile surgical saw blade used to resect damaged cartilage and/or bond in an orthopaedic reconstructive procedure such as a total knee replacement.
Reason for recall
Various reciprocating and oscillating saw blades were incorrectly labeled. The labeling errors include: (1) The pouch says oscillating saw blade when it actually contains a reciprocating saw blade; (2) The box bar code date does not match the human readable expiration date; and (3) The label incorrectly states use with Zimmer/Synthes handset and not the Zimmer Universal Power System.
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-1115-2013. 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.