ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.
FDA Recall Z-1574-2014 · Posted 2014-05-09
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Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeHTT
Date Initiated2014-01-08
Date Terminated2015-01-20
Product Quantity30 cutting burs affected
Reason for Recall
Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product.
Firm Action
Anspach sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated January 13, 2014, to all affected customers. The letter described the product, the problem and actions to be taken. If they have distributed any of the products to other services or facilities, customers were instructed to please forward this information as appropriate. Customers with questions you contact Anspach Customer Support at (800) 327-6887, option 3 or email [email protected].. Customers were asked to complete the attached reply form confirm receipt of the letter, return the completed form by fax to 800-327-6661.
For questions regarding this recall call 561-494-3706.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution including FL, TX, NC, IL, CO, and PA.
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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