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U.S. Department of Health and Human Services

Class 2 Device Recall AnspacSingle use Sterile bone cutting burs

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 Class 2 Device Recall AnspacSingle use Sterile bone cutting burssee related information
Date Initiated by FirmMarch 31, 2011
Date PostedJanuary 27, 2014
Recall Status1 Terminated 3 on July 18, 2019
Recall NumberZ-0829-2014
Recall Event ID 67176
510(K)NumberK011444 K974025 
Product Classification Motor, drill, electric - Product Code HBC
ProductAnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.5mm x 4mm screw. Rx only Single use Sterile bone cutting burs.
Code Information Lot #'s: D293037349, D323038110 and D363039140
Recalling Firm/
Manufacturer		 The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens FL 33410-4235
For Additional Information ContactCustomer Service
800-327-6887
Manufacturer Reason
for Recall		Cutter was longer than was stated on the label
FDA Determined
Cause 2		Pending
ActionAnspach 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.
Quantity in Commerce599 cutting burs
DistributionWorldwide Distribution - USA including CA, CO, IN, KY, MD and TX and Internationally to Japan, Taiwan, United Kingdom, Sweden, and Germany.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HBC
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