Synthes Tensioning Device The Synthes Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
- Company
- Synthes Usa (Hq), Inc.
- Recall Initiated
- July 31, 2013
- Posted
- November 25, 2013
- Terminated
- June 1, 2015
- Recall Number
- Z-0388-2014
- Quantity
- 369
- Firm Location
- West Chester, PA
Reason for Recall
All lots of the Synthes Tensioning Device were recalled due to the potential for the reaction fork to come loose from the main body of the device and not allow the wire to release, nor the device to apply tension.
Distribution
Nationwide Distribution.
Lot / Code Info
all lots of model number 03.311.001: Part # Synthes lot # 03.311.001 1934765 03.311.001 1934766 03.311.001 1993844 03.311.001 3036688 03.311.001 3398576 03.311.001 3776484 03.311.001 5100597 03.311.001 5106354 03.311.001 5160872 03.311.001 5160875 03.311.001 5174253 03.311.001 5174253 03.311.001 5174254 03.311.001 5181000 03.311.001 5181001 03.311.001 5196282 03.311.001 5196283 03.311.001 5197081 03.311.001 5241942 03.311.001 5241943 03.311.001 5336723 03.311.001 5363637 03.311.001 5396016 03.311.001 5411479 03.311.001 5555521
Root Cause
Device Design
Action Taken
Synthes sent an Urgent: Medical Device Recall letter dated July 31, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. "Please remove this product from your inventory and return it to Synthes. A replacement product will be sent to you when available. If you DO have any of the identified devices, please take the following steps: "Call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. "Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, telephone number and signature in the spaces provided. "Return the Verification Form (page 3 of this letter) with the product to: " Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If you DO NOT have the identified product, please take the following steps: "Complete the attached Verification Section at the end of this letter by checking the appropriate box indicating that no affected product has been located. Please include your name, title, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device removal information. "Return the document to Synthes by: Fax: 877-272-3517 "Email: FieldAction@synthes.com If you have any questions, please call 610-719-5450 or email Fieldaction@synthes.com We apologize for any inconvenience this may cause and thank you in advance for your attention and cooperation.