—#118956

Product

Stryker TPS Universal Driver REF 5100- 99 Rx , The Stryker Total Performance System (TPS) is intended for use in 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 are also used in the placement of screws, wires, pins, and other fixation devices.

FDA product code: ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K040300
Affected lot / code info: Serial Number 0214200753

Why it was recalled

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 (FDA determination)

Process change control

Action the firm took

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 receiving this form, Stryker will send you a pre-paid shipper to send your affected device(s)back to Stryker to be reprogrammed with the correct specifications. Send back all affected devices using the pre-paid shipper provided to you by Stryker. If you require a loaner, please contact the Stryker Service Department to arrange for a loaner at 888-308-1983. For questions regarding this recall please Stryker Instruments: Monday-Friday 8am-5pm (EST) 269-389-4518 / 269-389-3808 kara.spath@stryker.com / jennifer.mars@stryker.com.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E Milham Ave, Portage, Michigan 49002-9704

Distribution

Distribution pattern: Worldwide distribution: US (nationwide) including states of: AZ, FL, GA, NC, NY, SC, TX and VA; and countries of: India, Netherlands and Japan.

Timeline

Recall initiated: 2013-07-01
Posted by FDA: 2013-07-16
Terminated: 2013-09-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118956. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.