.***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 Recall Z-2077-2012 · Posted 2012-07-25
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Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeHTW
Date Initiated2011-09-19
Date Terminated2013-07-25
Product Quantity5 each
Reason for Recall
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.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
US Nationwide Distribution including the states of: Arizona. and California.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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