Z-2099-2013Class II

Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S...

Name: Z-2099-2013 Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2013-07-08
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2013-07-08 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The... on 2013-07-08. FDA classified it as Class II and gives the reason as "Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect". 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-2099-2013
Classification: Class II
Status: Terminated
Initiated: 2013-07-08
Posted: 2013-08-27
Terminated: 2015-03-31
Recalling firm: Howmedica Osteonics Corp
Product: Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot R11482, was incorrect.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Stryker sent an Urgent Medical Device Removal letter dated July 8, 2013 via Fed Ex to all affected customers. The letter identified the affected product, product issues, potential hazards, risk mitigation and actions to be taken. Customers were instructed to return all affected products available to Stryer Osteosynthesis or contact Stryer customer service and complete and sign the enclosed Business Reply Form and fax a copy to: 1-865-251-3635. Questions can be directed to Stryker at 201-972-2100.
Quantity in commerce: 23 units
Distribution: USA Nationwide Distribution in the states of: FL. OH, TX, & VA
Product codes and lots: Catalog # 604640, Lot Code R11428 21 units Catalog # 604642S, Lot Code R09071 1 unit

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2099-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2099-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-04	2013-08-27

Product code HWC

K000080Class IIAsnis III Cannulated Screw SystemHowmedica Osteonics Corp. / cleared 2000-04-03

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

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)