Date Initiated by Firm | October 14, 2013 |
Date Posted | November 26, 2013 |
Recall Status1 |
Terminated 3 on August 18, 2015 |
Recall Number | Z-0404-2014 |
Recall Event ID |
66581 |
510(K)Number | K111667 |
Product Classification |
Nail, fixation, bone - Product Code JDS
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Product | Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar
Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic fractures, and tibial malunions and non-unions. |
Code Information |
part no. 03010.438S, lot 706802 |
Recalling Firm/ Manufacturer |
Synthes (USA) Products LLC 1301 Goshen Pkwy West Chester PA 19380-5986
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For Additional Information Contact | Customer Support 610-719-6500 |
Manufacturer Reason for Recall | Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar. |
FDA Determined Cause 2 | Labeling mix-ups |
Action | Synthes sent an Urgent Notice: Medical Device Recall letter dated October 14, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 if they have any of the affected product to obtain a Return Authorization Number, complete the Verification Section at the end of the letter and return the Verification Form with the affected product to:
Credit/Returns
Synthes
1101 Synthes Avenue
Monument, CO 80132
If customers do not have the affected product they should complete the attached Verification Section and return all documents to Synthes by:
Fax: 866-229-7778
Scan/email: FieldAction@synthes.com
Customers with questions were instructed to call 610-719-5450.
For questions regarding this recall call 610-719-5000. |
Quantity in Commerce | 55 |
Distribution | Nationwide Distribution |
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 = JDS
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