Stryker Endoscopy Recalls Formula Shaver Handpieces Due to Routine Check Concerns
Stryker Endoscopy is recalling 34 Formula and Formula 180 Shaver Handpieces because routine checks to ensure accuracy and fitness for use may not have been adequately determined.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where routine checks for accuracy and fitness for use may not have been adequately determined, representing a risk-of-harm product where injury has not yet been reported, consistent with the 'High' severity criteria.
Plain-English summary
Stryker Endoscopy is recalling 34 units of the Formula Shaver Handpiece (with buttons) and Formula 180 Shaver Handpiece (with button). These medical devices are components of the Crossfire System used for abrasion, resection, debridement, and removal of bone and soft tissue, as well as ablation, coagulation, and hemostasis.
The recall was initiated because Stryker Endoscopy determined that there may not have been adequate determination of required routine checks to ensure the accuracy and fitness for use of specific serial numbers of the Formula and 180 Shaver Hand Control. The affected devices were distributed worldwide, including in the United States (nationwide, with specific mentions of CA, FL, IA, MI, NV, NC, OK, TX, and WI) and in China and Great Britain.
Healthcare providers and facilities should identify the affected devices by checking the serial numbers listed in the recall notice. The specific serial numbers include 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, and 12B055774. Users should contact Stryker Endoscopy for instructions on how to proceed with the recall.
The recalled product
- 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…
- Manufacturer
- Stryker Endoscopy
- Affected units
- 34
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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