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.
Recall
- Recall Number
- Z-0779-2014
- Event Number
- 67179
- Firm
- The Anspach Effort, Inc.
- FEI Number
- 1045834
- Product Code
- ERL
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- May 6, 2013
- Posted
- January 16, 2014
- Terminated
- April 18, 2016
- Address
- 4500 Riverside Drive, Palm Beach Gardens, FL, 33410-4235
Description
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.
Product did not reach expected sterility assurance level
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].
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.
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