Anspach MIA 16 (16cm Minimally Invasive Attachment), Rx Only MIA16 attachments are intended for use with Motor Systems for cutting and shaping bones, including the spine and cranium.
FDA Recall Z-0779-2014 · Posted 2014-01-16
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Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeERL
Date Initiated2013-05-06
Date Terminated2016-04-18
Product Quantity183
Reason for Recall
Product did not reach expected sterility assurance level
Firm Action
The firm, Aspach, sent an "URGENT: MEDICAL DEVICE LABELING CORRECTION" letter dated May 13, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The consignees/ customers were instructed that Sterrad 100S system should not be used on the MIA 16 attachment (the information only applies to only Sterrad sterilization of this devices and not to any other attachments.), and complete and return the Return Receipt Requested Customer Reply form via fax to: 1-800-327-6661 or email: [email protected]. If you distribute any of the products to other services or facilities, please forward this information as appropriate.
Should you have any queries, please do not hesitated to contact Anspach Product Support at (800) 327-6887. Hours of Operation are 8:30am-5:30pm Eastern Standard Time or email: [email protected].
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
Nationwide Distribution: FL, IL, CA. IN, MI, CA, NJ, TX, NE, NC, OR, PA, TN, DC, UT, CO, MO, KY, MD, WV, NY, and MN.
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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