—#124879

Product

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 product code: ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K011444, K965080
Affected lot / code info: ALL LOTS

Why it was recalled

Product did not reach expected sterility assurance level

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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: ProductSupportTeam@synthes.com. 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: ProductSupportTeam@synthes.com.

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Drive, Palm Beach Gardens, Florida 33410-4235

Distribution

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.

Timeline

Recall initiated: 2013-05-06
Posted by FDA: 2014-01-16
Terminated: 2016-04-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124879. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.