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Terminated

Cutting Burr labeled in part:"***S-1504TD QTY:1***Twist Drill for 1.5 mm x 4 mm Screw. Use with SHORT Attachments.***ANSPACH***Manufacturer Made in USA***The Anspach Effort, Inc***4500 Riverside Drive***Palm Beach Gardens, FL 33410, USA***Tel (800) 327 6887 / +1 561 627 1080***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Place***High Wycombe HP11 1LA***United Kingdom***Tel: +441494616126***Sterilized using Irradiation***Do Not Re-use***Keep Dry***Caution; consult accompanying documents***Sterile unless damaged or opened***Rx Only***". Cutting and shaping bone including bones of the spine and cranium.

FDA Recall Z-3202-2011 · Posted 2011-09-14

Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeHBC
Date Initiated2011-03-17
Date Terminated2011-10-11
Product Quantity599

Reason for Recall

The Anspach Effort, Palm Beach Gardens, FL, is recalling their Single Use, Sterile Bone Cutting Burrs, Catalog #, S-1504TD, Lot #s D363039140. D323038110, D293037349 and Catalog # TURQ-434-4, Lot #s D343038845, D323038131, due to the burr being 2.0 mm longer than stated on the label. As a result, a hole drilled using this burr would be 2 mm deeper than the screw.

Firm Action

Anspach Effort, Palm Beach Gardens, FL sent a Customer letter dated March 31, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customers were instructed to screen their inventory, contact Anspach Customer Support at (800) 327-6887 if any of the recalled product was found, and complete and return the attached reply form. If the product had been further distributed, they were asked that the recall information be forwarded as appropriate.

Root Cause

Mixed-up of materials/components

Distribution Pattern

Worldwide Distribution -- USA (nationwide) including the states of CA, CO, IN, KY, MD and TX. and the countries of Germany, Japan, Taiwan, United Kingdom and Sweden.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011444ANSPACH EMAX DRILL SYSTEMThe Anspach Effort, Inc. · 2001-08-08K974025ANSPACH SHIELDED ATTACHMENTThe Anspach Effort, Inc. · 1998-07-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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