Recalls / —
—#124868
Product
AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
- FDA product code
- HBC — Motor, Drill, Electric
- Device class
- Class 2
- Medical specialty
- Neurology
- 510(k) numbers
- K011444, K974025
- Affected lot / code info
- Lot #'s: D293037349, D323038110 and D363039140
Why it was recalled
Cutter was longer than was stated on the label
Root cause (FDA determination)
Pending
Action the firm took
Anspach sent an Urgent Medical Device Product Removal letter dated March, 32, 2013, to all affeced customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inventory their batches and return the products for replacement. Customers needing assistance were instructed to contact Anspach at 800-327-6887. For questions regarding this recall, call 800-327-6887.
Recalling firm
- Firm
- The Anspach Effort, Inc.
- Address
- 4500 Riverside Drive, Palm Beach Gardens, Florida 33410-4235
Distribution
- Distribution pattern
- Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.
Timeline
- Recall initiated
- 2011-03-31
- Posted by FDA
- 2014-01-27
- Terminated
- 2019-07-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #124868. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.