FDA Device recall Z-2086-2015
16mm Chisel Blade
- FDA Device
- Class II
- terminated
- Published 2015-07-22
On 2015-07-22 the FDA classified a Class II recall of 16mm Chisel Blade by Synthes Usa Products, citing it was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2086-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-24 |
| Published | 2015-07-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Products |
| Distribution | CA, FL, ID, IN, KS, MD, MI, MO, NC, NJ, NV, OH, TN, UT, VA, WA, WI |
Product
16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.
Reason
It was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade.
Identifiers
| code_info | Part Number 399.56 Lot Numbers T106341 |
|---|
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-2086-2015%22
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