| Class 2 Device Recall Synthes Spiral Blade Component of the Synthes Modular Blade Plate System | |
Date Initiated by Firm | October 27, 2010 |
Date Posted | February 16, 2011 |
Recall Status1 |
Terminated 3 on April 16, 2015 |
Recall Number | Z-1268-2011 |
Recall Event ID |
57318 |
510(K)Number | K080109 |
Product Classification |
Appliance, fixation, nail/blade/plate combination - Product Code KTW
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Product | 02.122.556S, 55mm Spiral Blade, 14mm,
Left-Sterile - 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. |
Code Information |
All lots of Part Number: 02.122.556S, 55mm Spiral Blade, 14mm, Left-Sterile |
Recalling Firm/ Manufacturer |
Synthes USA (HQ), Inc. 1302 Wrights Ln E West Chester PA 19380-3417
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For Additional Information Contact | Customer Support 610-719-5000 |
Manufacturer Reason for Recall | Potential for out of specification star grind teeth. |
FDA Determined Cause 2 | 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. |
Quantity in Commerce | 0 |
Distribution | Nationwide Distribution including AL, CA, GA, IA, IL, IN, MA, MI, MS, NC, NJ, NV, OH, PA, SC, SD, TN, and WV. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = KTW
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