Recall Z-2703-2011 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Linvatec Corp. dba ConMed Linvatec
"***LINVATEC SRS SHOULDER RESTORATION SYSTEM CrossFT 5.5mm CrossFT Suture Anchor with Two#2 (5 metric) Hi-Fi Sutures***SRS.Linvatec.com***ConMed Linvatec Biomaterials, Ltd. Hemiankatu 6-8L 33720 Tampere, FINLAND***STERILE EO***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA Made in USA***REF CFP-5502***" The non absorbable suture anchor is intended to reattach soft tissue to bone in o
| Date | Jun 29, 2011 (initiated Jan 26, 2011) |
| Status | Terminated |
| Reason | ConMed Linvatec, Largo, FL is recalling CrossFT Suture Anchor with Two #2 HI-Fi sutures, Lot 211581, Product Number CFP-5502. There is a possibility that the product may have been incorrectly assembled. The disposable driver may have the incorrect color handle (red versus black). |
| Root cause | Employee error |
| Action | ConMed Linvatec sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated January 27, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. Customers were instructed to check their inventory for affected lots and return for credit. A Reply Form and FedEx Air bill was enclosed with the letter for customers to complete and return with the product. Questions regarding the recall can be answered by contacting the Customer Service Department via e-mail at Custserv1@linvatec.com. |
| Quantity | 45 each |
| Distribution | Worldwide Distribution--USA (nationwide) and countries of Canada and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.