Class 2 Device Recall OCM Cutting Burrs (Cutters)

• Date Initiated by Firm: March 28, 2016
• Create Date: May 19, 2016
• Recall Status: Terminated on December 14, 2016
• Recall Number: Z-1668-2016
• Recall Event ID: 73738
• 510(K)Number: K131053
• Product Classification: Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
• Product: ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
• Code Information: Model/Catalog #: OCM7-2SD, 2.0 MM Diamond Ball, Lot Numbers: J473111699.
• Recalling Firm/ Manufacturer: The Anspach Effort, Inc.; 4500 Riverside Dr; Palm Beach Gardens FL 33410-4235
• For Additional Information Contact: Jennifer Breston; 561-494-3673
• Manufacturer Reason for Recall: Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.
• FDA Determined Cause: Process control
• Action: Consignees were sent an Urgent Notice of this Medical Device Recall on 3/28/2016 for their product Otologic Curved Micro (OCM) Diamond Ball Burr, with the following actions required: We have record that your facility has the product(s) subject to this recall (removal). DePuy Synthes asks that you review your inventory and immediately remove the affected lots from stock. Please take the following actions: If you DO HAVE any of the identified devices, please take the following steps: Complete the Verification Section (page 3 of this letter) by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, address, telephone number and signature in the spaces provided. Please contact Product Support at (800) 327-6887, option 1, to arrange for return of any unused product. A credit will be issued for returned product. Send a copy of the completed Verification Section (page 3) to Product Support by fax to (561) 627-2682. Send a copy of the completed Verification Section (page 3) to the Complaint Handling Unit by scan/email to RA-DPYUS-chu.pb@ITS.JNJ.com. If you DO NOT HAVE the identified product, please take the following steps: Complete the Verification Section by checking the appropriate box indicating that no affected product has been located. Please include your name, title, address, telephone number and signature in the spaces provided. This return documentation acknowledges your receipt of medical device recall (removal) information. Return the documents to The Anspach Effort by: Fax: (561) 627-2682 Scan/email: RA-DPYUS-chu.pb@ITS.JNJ.com Giving them to your DePuy Synthes Sales Consultant Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual of the notification.
• Quantity in Commerce: 27 devices
• Distribution: US Distribution in the states of KY and TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = ERL