Z-0904-2018 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
- 960
Product Description
3.0 mm Reaming Rod, with straight ball tip, 950 mm, sterile, Part Number: 351.76S 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 25-Apr-2017 to 22-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H306632 4/3/2017 2026-02-28 H311229 4/16/2017 2026-03-31 H311228 4/28/2017 2026-03-31 H311231 4/28/2017 2026-03-31 H319172 4/28/2017 2026-03-31 H319175 4/28/2017 2026-03-31 H318789 5/4/2017 2026-03-31 H319171 5/4/2017 2026-03-31 H327068 5/4/2017 2026-03-31 H311226 5/6/2017 2026-03-31 H311225 5/11/2017 2026-04-30 H311224 5/12/2017 2026-04-30 H327067 5/12/2017 2026-04-30 H327066 5/18/2017 2026-04-30