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Recall Observatory FDA recall evidence

Device product

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

Z-1383-2017

January 31, 2017

Class II

Product summary

Firm
Synthes (USA) Products LLC
Event
Event 76487
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-1383-2017

Official wording

Reason: 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.

Code information: Part numbers 03.820.350 Lot 5919005 and 03.820.352, lot 5919006

Distribution pattern: US distribution to TX and LA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.