Z-0905-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 14, 2018
- Initiation Date
- July 26, 2017
- Termination Date
- September 10, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21
Product Description
2.5 mm Guide Rod, with smooth tip, 950 mm, sterile, Part Number: 355.042S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Reason for Recall
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Distribution Pattern
Worldwide Distribution: US (Nationwide) to states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, the District of Columbia, including Puerto Rico, and country of: Canada.
Code Information
Distributed 31-May-217 to 20-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H354470 5/27/2017 2026-04-30