FDA Device recall Z-1866-2012
Formula Shaver Handpiece (with buttons)
- FDA Device
- Class II
- terminated
- Published 2012-07-04
On 2012-07-04 the FDA classified a Class II recall of Formula Shaver Handpiece (with buttons) by Stryker Endoscopy, citing 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 Fo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1866-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-21 |
| Published | 2012-07-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Endoscopy |
| Distribution | US |
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.
Identifiers
| code_info | Formula Shaver Hand Control, PN 375-704-500 and Formula 180 (PN 375-708-500). Serial numbers: 12B037204, 12B037214,…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. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1866-2012%22
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