—#144836

Product

ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.

FDA product code: ERL — Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device class: Class 2
Medical specialty: Ear, Nose, Throat
510(k) numbers: K131053
Affected lot / code info: Model/Catalog #:OCM7-15SD, 1.5 MM Diamond Ball, Lot Numbers: J473111704 and J473111705

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: US Distribution in the states of KY and TX.

Timeline

Recall initiated: 2016-03-28
Terminated: 2016-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #144836. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.