Z-1866-2012Class II

Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA...

Name: Z-1866-2012 Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA...
Creator: Stryker Endoscopy
Published: 2012-05-21
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2012-05-21 / Terminated / root cause: manufacturing process

FDA source

Stryker Endoscopy began a recall of Formula Shaver Handpiece (with buttons); Formula 180 Shaver Handpiece (with button) Rx only, Made USA.: Stryker Endoscopy 5900 Optical Court San Jose, CA 95138... on 2012-05-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1866-2012
Classification: Class II
Status: Terminated
Initiated: 2012-05-21
Posted: 2012-06-25
Terminated: 2012-09-20
Recalling firm: Stryker Corp.
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.
Product code: GFA Blade, Saw, General & Plastic Surgery, Surgical
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.
Root cause tag: manufacturing process
FDA 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 this letter please contact us at [email protected] or call 1-800-624-4422.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1866-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1866-2012	Class II	Terminated	Voluntary: Firm initiated	2012-07-04	2012-06-25

Product code GFA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)