Synthes (USA) Electric Pen Drive System

510(k) K043310

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK043310	Date5 Jan 2005Cleared	StatusActive

6 recalls · FDA

- Terminated Z-0681-2017 FDA Class II initiated 1 Nov 2016
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
- Terminated Z-2783-2016 FDA Class I initiated 24 Jun 2016
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
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
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
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.

1 jurisdiction

United States — FDA 510(k) Active

510(k)