Z-1311-2011

02.122.615, 115mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade...

Name: Z-1311-2011 02.122.615, 115mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade...
Creator: Synthes USA (HQ), Inc.
Published: 2010-10-27
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2010-10-27 / Terminated

FDA source

Synthes USA (HQ), Inc. began a recall of 02.122.615, 115mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and... on 2010-10-27. The reason FDA records is "Potential for out of specification star grind teeth". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1311-2011
Status: Terminated
Initiated: 2010-10-27
Posted: 2011-02-16
Terminated: 2015-04-16
Recalling firm: Synthes GmbH
Product: 02.122.615, 115mm Spiral Blade, 14mm, Right - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
Product code: KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Reason for recall: Potential for out of specification star grind teeth.
FDA root cause: Other
Action: Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time. Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number. Return the Verification Form with the recalled product to: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. For questions regarding this recall call 1-800-620-7025, x 6883.
Distribution: Nationwide Distribution including AL, CA, GA, IA, IL, IN, MA, MI, MS, NC, NJ, NV, OH, PA, SC, SD, TN, and WV.
Product codes and lots: All lots of Part Number: 02.122.615, 115mm Spiral Blade, 14mm, Right

Product code KTW

K080109Class IISynthes (USA) Modular Blade Plate SystemSynthes (Usa) / cleared 2008-03-20

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)