| ||Class 2 Recall|
Synthes Tensioning Device
||November 25, 2013
|Recall Event ID
Orthopedic Manual Surgical Instrument - Product Code LXH
||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.
||all lots of model number 03.311.001:
Part # Synthes lot #
|Synthes USA HQ, Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
|For Additional Information Contact
|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.
|DESIGN: Device Design
||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
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.
|Quantity in Commerce
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.