Date Initiated by Firm | August 12, 2011 |
Date Posted | August 06, 2012 |
Recall Status1 |
Terminated 3 on November 21, 2013 |
Recall Number | Z-2147-2012 |
Recall Event ID |
62395 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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Product | CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone. |
Code Information |
Lot #156920 |
Recalling Firm/ Manufacturer |
Linvatec Corp. dba ConMed Linvatec 11311 Concept Blvd Largo FL 33773-4908
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For Additional Information Contact | Roger Murphy 727-399-5205 |
Manufacturer Reason for Recall | ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion. |
FDA Determined Cause 2 | Use error |
Action | The firm sent an "URGENT: Medical Device Recall Notification" letter dated August 12, 2011, to its customers after initial phone notifications. The letter describes the product, problem and actions to be taken. The customers were instructed to: 1) Immediately check their facility's inventory for the product number and lot number listed in the letter. If the product is at their facility, they were instructed to discontinue the use of the product. 2) To return the products to ConMed Linvatec for credit and return the products and Reply Form. 3) If the product was transferred to another facility, complete the Reply Form documenting the transfer of the product, and return i by mail or fax. For questions, contact 727-399-5205. |
Quantity in Commerce | 2 |
Distribution | Nationwide Distribution, including the states of Colorado and Pennsylvania. |
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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