Z-1383-2017 Class II Terminated
FDA device recall Z-1383-2017 was initiated by Synthes (USA) Products LLC on January 31, 2017 and is designated Class II. 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 i… The recall status is terminated (terminated December 1, 2017). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 8, 2017
- Initiation Date
- January 31, 2017
- Termination Date
- December 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
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.
Distribution Pattern
US distribution to TX and LA
Code Information
Part numbers 03.820.350 Lot 5919005 and 03.820.352, lot 5919006