FDA Device recall Z-1710-2016
3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments tha…
- FDA Device
- Class II
- terminated
- Published 2016-06-01
On 2016-06-01 the FDA classified a Class II recall of 3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments tha… by Synthes Usa Products, citing the sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the steri….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1710-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-18 |
| Published | 2016-06-01 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).
Reason
The sterile packaging may be compromised. A protective cap is to be secured on the tip of the drill bit. If the protective cap is not secured, the drill bit may puncture the sterile barrier.
Identifiers
| code_info | Catalog ID 03.010.100S Lot # 5525872, 6153368, 6530901, 5548707, 6197315, 6581051 5575918, 6199232, 6676406, 5603463,…Catalog ID 03.010.100S Lot # 5525872, 6153368, 6530901, 5548707, 6197315, 6581051 5575918, 6199232, 6676406, 5603463, 6231850, 6721724 5649117, 6256560, 6734876, 5668880, 6305842, 6808463 5724639, 6319050, 6831468, 5742276, 6320150, 6997294 5807341, 6343980, 7039877, 6012770, 6401819, 7052565 6045597, 6448707, 7081479, 6057914, 6472100, 7378832 6108342, 6501856, 7410311, 6142443, 6503351, 7466207 7554670, 7620971, 7675571, 7711694, 7801251, 7918026 9815103, 9828932, 9905850, 9939769, H033348 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1710-2016%22
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