FDAFDA · Food and drugs·Recall number Z-2246-2018
Part no. 690.379, Graphic Case F/6.5mm Cannulated Screw Set
Published June 27, 2018 · Recall initiated: March 5, 2018
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
Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes (USA) Products LLC
- Distributor
- Distributed to accounts in CA, IL, IN, KS, LA, MD, NC, NE, NJ, OR, TX, and VA. Foreign distribution to Canada.
- Lot
- FL00860
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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