16mm Chisel Blade — Class II medical device recall Z-2086-2015
Terminated recall by Synthes (USA) Products LLC, reported 2015-07-22, distributed in CA, FL, ID, IN, KS, MD, MI, MO…. It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.
| Recall number | Z-2086-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2015-06-24 |
| Classified | 2015-07-16 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2016-08-18 |
| Distributed | CA, FL, ID, IN, KS, MD, MI, MO, NC, NJ, NV, OH, TN, UT, VA, WA, WI |
| Quantity | 100 |
| Lot numbers | T106341 |
| Model numbers | 399.56 |
Product
16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.
Reason for recall
It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.
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-2086-2015. 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.