Recall Z-1866-2012— Stryker Endoscopy
Class II · Terminated
Class II FDA medical device recall by Stryker Endoscopy, initiated 2012-05-21, terminated 2012-09-20. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Stryker Endoscopy
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-05-21
- Terminated
- 2012-09-20
- Firm location
- San Jose, CA, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.