Z-1846-2013Class II

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

Name: Z-1846-2013 GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2013-05-21
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2013-05-21 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device... on 2013-05-21. FDA classified it as Class II and gives the reason as "Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails". 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-1846-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-21
Posted: 2013-07-31
Terminated: 2014-10-14
Recalling firm: Howmedica Osteonics Corp
Product: GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary nail and set screw. The kit is used in combination with lag screw and (distal) locking screws and end cap as well.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 5 units
Distribution: US Distribution including the states of IL, KY and TN.
Product codes and lots: Catalog Number- 33250400S Catalog Number 33250360S

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1846-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1846-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-07-31

Product code HSB

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)