ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number 00702109200, STERILE, Single-use. Made is USA. ST ULTRAPOWER Di
FDA device recall Z-2041-2009 · posted 2009-09-08 · Terminated
Recall details
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Reason for recall
- ConMed Linvatec is recalling Ultrapower Bur, Diamond Wheel for possibility of a packaging breach in the sterile barrier.
- Action taken
- 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.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- HTT
- Quantity affected
- 2502
- Distribution
- Worldwide Distribution
- Date initiated
- 2009-07-31
- Date posted
- 2009-09-08
- Date terminated
- 2010-05-11
- Location
- Largo, FL
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