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.
Reported: May 25, 2016 Initiated: March 28, 2016 #Z-1667-2016
Product Description
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.
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.
Details
- Recalling Firm
- The Anspach Effort, Inc.
- Units Affected
- 27 devices
- Distribution
- US Distribution in the states of KY and TX.
- Location
- Palm Beach Gardens, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by The Anspach Effort, Inc.. Units affected: 27 devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 25, 2016. Severity: Moderate. Recall number: Z-1667-2016.
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