| Class 2 Device Recall Synthes MultiVector Distractor, Multiaxial Mandible Distractor (Right), Part Number 487.966 | |
Date Initiated by Firm | January 11, 2013 |
Date Posted | March 01, 2013 |
Recall Status1 |
Terminated 3 on August 31, 2015 |
Recall Number | Z-0904-2013 |
Recall Event ID |
64195 |
510(K)Number | K010690 |
Product Classification |
Screw, fixation, intraosseous - Product Code DZL
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Product | Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966.
For mandibular bone lengthening. |
Code Information |
Part number 487.966 - Lot numbers 7823465, 3817114, 7806086, 3824427, 3808871, 3794465, and 7793336. |
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 | It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. |
FDA Determined Cause 2 | Device Design |
Action | The firm, Synthes (USA) sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated January 11, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firmat 610-719-5450 for questions regarding this notice. |
Quantity in Commerce | 24 |
Distribution | Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT. |
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 = DZL
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