Device product
2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Z-0906-2018
Product summary
- Event
- Event 79157
- Status
- Terminated
- Classification
- Class II
- Quantity
- 63
- Official record key
device-enforcement:Z-0906-2018
Official wording
Reason: Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
Code information: Distributed 12-May-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H270855 5/12/2017 2026-04-30
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.
Derived failure modes
-
Unknown
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.