Recall Z-1866-2012 ยท GFA Blade, Saw, General & Plastic Surgery, Surgical
Stryker Endoscopy
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 bloo
| Date | Jun 25, 2012 (initiated May 21, 2012) |
| Status | Terminated |
| Reason | 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 | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 34 devices |
| Distribution | Worldwide distribution: USA (nationwide) including states of: CA, FL, IA , MI, NV, NC, OK, TX, and WI; and countries of: China and Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.