Recall Z-0830-2014
The Anspach Effort, Inc. · initiated March 31, 2011
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
Codes / lots: Lot #'s: D323038131 and D343038845
Reason for recall
Cutter was longer than was stated on the label
FDA-determined cause: Pending
Action taken
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.
Details
- Recall number
- Z-0830-2014
- Initiated
- March 31, 2011
- Posted by FDA
- January 27, 2014
- Terminated
- July 18, 2019
- Product code
- GFF – Bur, Surgical, General & Plastic Surgery
- Quantity
- 29 cutting burs
- Distribution
- Worldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.
- Recalling firm
- The Anspach Effort, Inc., Palm Beach Gardens, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0829-2014 Class II | AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm…Cutter was longer than was stated on the label | 03/31/2011Terminated |