Recalls / —

—#124869

Product

Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.

FDA product code

GFF — Bur, Surgical, General & Plastic Surgery

Device class

Class 1

Medical specialty

General, Plastic Surgery

510(k) numbers

K011444, K974025

Affected lot / code info

Lot #'s: D323038131 and D343038845

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 #124869. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.