Z-0975-2013 Class II Terminated
FDA device recall Z-0975-2013 was initiated by Orthohelix Surgical Designs Inc on October 30, 2012 and is designated Class II. Reason for recall: The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire. The recall status is terminated (terminated December 5, 2013). Affected quantity: Lot # 2399041, 97 pcs; Lot # 2399051, 143 pcs; Lot # 2399051R, 4 pcs & Lot # 2399061, 119 pcs.
Recall Details
- Product Type
- Devices
- Report Date
- April 3, 2013
- Initiation Date
- October 30, 2012
- Termination Date
- December 5, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Lot # 2399041, 97 pcs; Lot # 2399051, 143 pcs; Lot # 2399051R, 4 pcs & Lot # 2399061, 119 pcs
Product Description
Intraosseous Fixation System (IFS) 1.7 mm, 2.0 mm & 2.5 mm Cannulated Drill Bit. Intended to stabilize and aid in fixation of fractures.
Reason for Recall
The firm was notified by a customer that there was a burr on the inside end of the drill bit resulting in the drill bit not fitting over the associated guide wire.
Distribution Pattern
Nationwide Distribution including the states of CA, CO, IL, MI, MD, NC, NM, OH, OK, PA, SD, TX, UT, VA, WA and WI.
Code Information
Part #: IFS-072-17-C, Lot #: 2399041; Part #: IFS-72-20-C, Lot #: 2399051 & Lot #: 2399051R and Part #: IFS-072-25-C, Lot #: 2399061.