GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah

FDA device recall Z-1846-2013 · posted 2013-07-31 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.

Action taken

Stryker sent notification letters and product accountability forms dated May 21, 2013. via Fed Ex with return receipt to all branches/agencies and on May 22, 2013, via Fed Ex with return receipt to all hospital risk management, chief of orthoapedics, and surgeons. Our records indicate that you may have received and/or used the above referenced product(s). It is Stryker's responsibility as the manufacturer to ensure that customers who may have received and/or used these affected products also receive this important communication. Please contact your Stryker Sales Representative to arrange for return of the product if you have any of the above listed items. Please assist us in meeting our regulatory obligation by faxing back the attached Product Recall Acknowledgment Form as soon as possible to 855- 251-3635. Please note that your signature on the following form only confirms that you received this notification and does not obligate you to take any additional action beyond what is called for in this notification letter. We regret any inconvenience this action may cause you and if you have any questions, please call (201) 972-2100.

Root cause

Process control

Status

Terminated

Product code

HSB

Quantity affected

5 units

Distribution

US Distribution including the states of IL, KY and TN.

Date initiated

2013-05-21

Date posted

2013-07-31

Date terminated

2014-10-14

Location

Mahwah, NJ