Recall Z-2249-2010 ยท KDC Instrument, Surgical, Disposable
Linvatec Corp. dba ConMed Linvatec
REF 9903, DIGIT TRAP FINGER GRASPING DEVICE, LARGE STERILE. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA. Intended for use in small joint arthroscopic procedures.
| Date | Aug 24, 2010 (initiated Jan 28, 2010) |
| Status | Terminated |
| Reason | This recall was due to the possibility that the products may have a breach in the poly-Tyvek pouch that could potentially compromise the sterility of the contents. |
| Root cause | Material/Component Contamination |
| Action | Each consignee will be notified of the recall by an Urgent Medical Device Recall Notification letter sent by FedEx or an equivalent method. The letter identified the affected product, explained the reason for recall, and health risk. Consignees were instructed to examine their inventory and segregate the affected product for return. Customers are to complete and return the Reply Form and to notify their customers if the product was further distributed. Consignees are instructed to return any remaining product to ConMed Linvatec. Questions should be directed to the Customer Service departm |
| Quantity | 35,451 total |
| Distribution | Worldwide Distribution -- United Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Germany, Denmark, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, Republic of Korea, Netherlands, Portugal, Serbia, Singapore, Slovenia, El Salvador, Thailand, Taiwan, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.