High FDA (Devices)·Z-1866-2012·Announced 2012-07-04

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.

What this means for you

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
Category: Medical Device — Surgical Instrument
Hazard: device-malfunction
lack-of-verification
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

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Same manufacturer · Stryker Endoscopy

See all →

Moderate
Stryker PneumoSure Insufflators Recalled for Flow Rate Drop
FDA (Devices) · 2016-05-04
Severe
Stryker Recalls SERFAS 90 Degree Energy Probes Due to Fragmentation
FDA (Devices) · 2015-07-01
Moderate
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling
FDA (Devices) · 2014-12-24
Moderate
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions
FDA (Devices) · 2014-12-24
Moderate
Stryker Endoscopy Recalls Allis Forceps Due to Sterilization Instructions
FDA (Devices) · 2014-12-24

Same hazard · device malfunction