FDAFDA · Food and drugs·Recall number Z-1383-2017
PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Used to hold the disc segment open and facilitate discectomy
Published March 8, 2017 · Recall initiated: January 31, 2017
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
These items are incorrectly etched and labeled. The item etched and labeled as 10mm Strut 03.820.350 lot 5919005 is a 12 mm Strut. The item etched and labeled as 12 mm Strut 03.820.352 lot 5919006 is a 10 mm Strut.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes (USA) Products LLC
- Distributor
- US distribution to TX and LA
- Lot
- Part numbers 03.820.350 Lot 5919005 and 03.820.352, lot 5919006
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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