Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10887587013039 UDI-DI	Date21 Sep 2018Listed	StatusListed GUDID: in commercial distribution

Recalls

6 recalls · FDA

- Terminated Z-0681-2017 FDA Class II initiated 1 Nov 2016 on shared 510(k) K043310
Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.
2 recalls, same reason
- Terminated Z-2784-2016 FDA Class I initiated 24 Jun 2016 on shared 510(k) K043310
- Terminated Z-2783-2016 FDA Class I initiated 24 Jun 2016 on shared 510(k) K043310
There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.
- Terminated Z-2199-2016 FDA Class II initiated 31 May 2016 on shared 510(k) K043310
DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard.
- Terminated Z-1313-2015 FDA Class II initiated 19 Dec 2014 on shared 510(k) K043310
In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive was not labeled correctly, and the on and lock labels were interchanged.
- Terminated Z-0615-2014 FDA Class II initiated 15 Apr 2013 on shared 510(k) K043310
Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The "on" and "lock" labels were interchanged.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — GUDID listing Listed

GUDID

Show all (12)