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Recall Observatory FDA recall evidence

Device product

2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Z-0903-2018

July 26, 2017

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 79157
Status
Terminated
Classification
Class II
Quantity
1144
Official record key
device-enforcement:Z-0903-2018

Official wording

Reason: Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

Code information: Distributed 10-Mar-2017 to 23-Jun-2017; Lot Number Manufacturing Date (M/D/YYYY) Expiration Date (YYYY-MM-DD): H311894 3/9/2017 2026-01-31 H311912 3/9/2017 2026-01-31 H311913 3/9/2017 2026-01-31 H311941 3/9/2017 2026-01-31 H311942 3/9/2017 2026-01-31 H311925 3/14/2017 2026-01-31 H311938 3/14/2017 2026-01-31 H311924 4/9/2017 2026-01-31 H334430 4/13/2017 2026-02-28 H334555 4/13/2017 2026-02-28 H334556 4/19/2017 2026-02-28 H336080 4/19/2017 2026-03-31 H336081 4/19/2017 2026-03-31 H336083 4/19/2017 2026-03-31 H317169 5/10/2017 2026-03-31 H317170 5/10/2017 2026-03-31

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

    reason.no_named_rule · v1.0.0

    Possible lack of product sterility due to potential gaps/channeling in the seal of the package.