Recall Z-1741-2013 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Stryker Instruments Div. of Stryker Corporation
CORE Universal Driver REF 5400- 99 Rx Only This drill may also be used with theTotal Performance System (TPS").The Stryker Total Performance System (TPS) is intended for usein the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental orthopedic, maxillofacial, spinal, and plastic surgery. The instruments ar
| Date | Jul 16, 2013 (initiated Jul 1, 2013) |
| Status | Terminated |
| Reason | The safety margin values detailed in the Engineering Design were entered incorrectly into the programming software. Handpieces that have been programmed with the incorrect parameters could result in unintended activation. There is a potential for injury to the patient or user as a result of unintended forward or reverse activation. There is also the potential that the handpiece may not reach 100 |
| Root cause | Process change control |
| Action | The firm, Stryker Instruments, sent emails beginning May 30, 2013 "URGENT MEDICAL DEVICE CORRECTION" letter dated July 1, 2013 to its customers. The letter identified the device, the reason for the recall, possible adverse events and actions to be taken. The customers were instructed to immediately review this letter, locate the units listed, complete and return the business reply form via FAX to 866-521-2762; or email Kara.spath@stryker.com; if you have further distributed this product, please forward this letter and the attached Business Reply Form to all affected locations. After receivin |
| Quantity | 11 |
| Distribution | Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040300 | STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) Stryker Instruments, Mar 3, 2004 |