Recall Z-1668-2016 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
The Anspach Effort, Inc.
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.
| Date | Mar 28, 2016 |
| Status | Terminated |
| Reason | 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 | 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 pr |
| Quantity | 27 devices |
| Distribution | US Distribution in the states of KY and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131053 | ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM The Anspach Effort, Inc., Dec 31, 2013 |