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
Reported: March 8, 2017 Initiated: January 31, 2017 #Z-1383-2017
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- Synthes (USA) Products LLC
- Units Affected
- 2 units
- Distribution
- US distribution to TX and LA
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Synthes (USA) Products LLC. Units affected: 2 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 8, 2017. Severity: Moderate. Recall number: Z-1383-2017.
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