—#109573

Product

Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 Components within the Crossfire System that provided abrasion, resection, debridement and removal of bone and soft tissue through the Formula Shaver and blade, and the ablation and coagulation of soft tissue, as well as hemostasis of blood vessels through its SERFAS Energy electrosurgical probe.

FDA product code: GFA — Blade, Saw, General & Plastic Surgery, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: Formula Shaver Hand Control, PN 375-704-500 and Formula 180 (PN 375-708-500). Serial numbers: 12B037204, 12B037214, 12B037224, 12B037234, 12B040594, 12B040604, 12B040614, 12B040624, 12B040634, 12B040644, 12B040654, 12B040664, 12B040684, 12B041374, 12B046934, 12B046964, 12B046974, 12B046994, 12B047004, 12B047014, 12B047024, 12B047034, 12B047054, 12B047064, 12B047074, 12B047084, 12B047094, 12B049204, 12B049234, 12B049244, 12B055744, 12B055754, 12B055764, 12B055774.

Why it was recalled

Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure accuracy and fitness for use of specific serial numbers of Formula and 180 Shaver Hand Control.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The firm, Stryker Endoscopy, sent an "Urgent: Device Removal" letter dated May 21, 2012 to all affected customers via Federal Express. Stryker Sales Reps were notified by e-mail on the same day. Stryker international sites were notified by e-mail on May 24, 2012. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their inventory for part and serial number; quarantine any of the affected product, call Stryker Endoscopy's Customer Service at 1-800-624-4422 for replacements and return affected product. If you have any questions regarding this letter please contact us at shavers@stryker.com or call 1-800-624-4422.

Recalling firm

Firm: Stryker Endoscopy
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide) including states of: CA, FL, IA , MI, NV, NC, OK, TX, and WI; and countries of: China and Great Britain.

Timeline

Recall initiated: 2012-05-21
Posted by FDA: 2012-06-25
Terminated: 2012-09-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #109573. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.