Synthes Electric Pen Drive — Class II medical device recall Z-1313-2015
Terminated recall by Synthes, Inc., reported 2015-04-01, distributed nationwide. In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric Pen Drive wa
| Recall number | Z-1313-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2014-12-19 |
| Classified | 2015-03-23 |
| Reported by FDA | 2015-04-01 |
| Terminated | 2016-05-19 |
| Distributed | Nationwide (US) |
| Quantity | 249 |
| Reason classes | labeling |
| Lot numbers | AV18166, AV19044, AV20666 |
| Model numbers | 05.001.012 |
Product
Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery.
Reason for recall
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.
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-1313-2015. 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.