ClearanceBrief
Recall Z-3193-2011 ยท HBC Motor, Drill, Electric

The Anspach Effort, Inc.

Sterile Bone Cutting Burrs model SIL-7-9 labeled in part:***SIL-7-9***QTY: 1***9 mm Fluted Ball.***Use with B-Silber***Attachment.***Use by 2015-01***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***EC REP***Anspach Europe Ltd.***Aston Court, Kingsmead Business Park***Frederick Plac

DateSep 13, 2011 (initiated May 9, 2011)
StatusTerminated
ReasonThe Anspach Effort, Inc., Palm Beach Gardens, FL, is recalling their Anspach Single Use, Sterile Bone Cutting Burrs, catalog numbers, IMRI-S-8NS-M, M-6P, QD8-4OVD, S-5B-4, and SIL-7-9, lot #'s C323023789, C403026551, C473028567, C403026563, D153034013, D173034385, and C363024789, because the bar code which defines the expiration date may be incorrect. This could cause the bar code reader system to
Root causeEmployee error
ActionThe Anspach Effort, Inc. sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated May 27, 2011 to all affected customers. The letter described the product, problem, and the actions to be taken by the customers. The letter instructs customers to check their inventory and to segregate any affected product found. A Customer Response Form was attached for customers to complete and return to the firm via fax at 1-800-327-6661. Contact Anspach Customer Support at 800-327-6887 for questions regarding this recall.
Quantity49
DistributionWorldwide Distribution--USA (nationwide) including the states of Alabama, California, and Wisconsin and the countries of Columbia, France, Germany, Great Britain, Italy, Panama, Poland, Saudi Arabia, South Africa, Spain, and Switzerland.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.