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Terminated

16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MIA16-G1

FDA Recall Z-1037-2015 · Posted 2015-02-02

Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeHBC
Date Initiated2014-12-10
Date Terminated2016-05-09
Product Quantity8

Reason for Recall

Customer complaint indicating the color bands on the MIA16-G1 were not correct.

Firm Action

Anspach sent an "URGENT MEDICAL DEVICE RECALL" (Removal) letter dated December 10, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm requested the customer to 1) Immediately identify and set aside all product listed below 2) Review, complete, sign and return the attached reply form 3) Share this letter with others in your facility that need to be made aware of this recall 4) If you distribute any of the affected products to other services or facilities, please forward this letter as appropriate 5) Maintain awareness of this notice 7) Keep a copy of this notice. If you have any questions regarding this removal, please contact the Complaint Handling Unit Manager at 561-494-3673 or contact your Anspach Sales Representative.

Root Cause

Environmental control

Distribution Pattern

US Distribution to the states of: NC and CA., and Internationally to Switzerland.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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