Recall Z-2041-2009 ยท HTT Burr, Orthopedic
Linvatec Corp. dba ConMed Linvatec
ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number 00702109200, STERILE, Single-use. Made is USA. ST ULTRAPOWER Diamond Wheel/MDS M-51, (MUSTARD) 25.4 mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702129200, STERILE. Made in USA. ST ULTRAPOWER Diamond Wheel/MDS AM-51, (LIME) 25.4mm For Use with Low or Medium Speed Drills Only, Catalog Number 00702139200, STERILE. M
| Date | Sep 8, 2009 (initiated Jul 31, 2009) |
| Status | Terminated |
| Reason | ConMed Linvatec is recalling Ultrapower Bur, Diamond Wheel for possibility of a packaging breach in the sterile barrier. |
| Root cause | Package design/selection |
| Action | Firm notified international and domestic consignees by an Urgent Medical Device Recall letter on July 31, 2009. Customers were asked to check their inventory; complete, sign, and return the enclosed Reply Form; and return the devices for credit. Questions should be directed to Customer Service at 1-800-237-0169. |
| Quantity | 2502 |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.