FDAFDA · Food and drugs·Recall number Z-1472-2019
Drill for 3.5mm screw, 2.5x120mm, AO, Item Number ST502015216
Published May 29, 2019 · Recall initiated: April 8, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer GmbH
- Distributor
- The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
- Lot
- All items marked with "Normed" are affected
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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