—#110229

Product

.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium.

FDA product code: HTW — Bit, Drill
Device class: Class 1
Medical specialty: Orthopedic
510(k) numbers: K061297, K974025
Affected lot / code info: Lot numbers E203050779 and E383055709.

Why it was recalled

Anspach Effort, Inc. Palm Beach Gardens, FL is recalling their Single Use Sterile Bone Cutting Burrs used with XMax, microMax, microMax Plus, eMax, eMax2 and eMax2 Plus High Speed Drill Systems. It is possible for the cutter to come apart.

Root cause (FDA determination)

Device Design

Action the firm took

The firm, Anspach, sent an "URGENT: Medical Device Product Removal" letter dated December 15, 2011, to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: 1) Screen their inventory immediately for any of the batches listed in the letter. 2) If they have any of the products listed, contact Anspach Customer Support at (800) 327-6887 to arrange for their immediate return and replacement. 3) Complete and return the attached Customer Reply form indicating if the item(s) are being returned and confiming their receipt of this letter, and fax to 1-800-327-6661. If they have distributed any of the products to other services or facilities, please forward this information as appropriate. Should you have any queries, please do not hesitate to contact Anspach Customer Support at (800) 327-6887.

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Drive, Palm Beach Gardens, Florida 33410-4235

Distribution

Distribution pattern: US Nationwide Distribution including the states of: Arizona. and California.

Timeline

Recall initiated: 2011-09-19
Posted by FDA: 2012-07-25
Terminated: 2013-07-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110229. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.