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

FDA device recall Z-1866-2012 · posted 2012-06-25 · Terminated

Recall details

Recalling firm

Stryker Endoscopy

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.

Action taken

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 shavers@stryker.com or call 1-800-624-4422.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GFA

Quantity affected

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.

Date initiated

2012-05-21

Date posted

2012-06-25

Date terminated

2012-09-20

Location

San Jose, CA