Synthes (USA) Products LLC: Medical Device Recall in 2017 - (Recall #: Z-1383-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: January 31, 2017

Date Posted: March 8, 2017

Recall Number: Z-1383-2017

Event ID: 76487

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.

Status: Terminated

Product Quantity: 2 units

Code Information:

Part numbers 03.820.350 Lot 5919005 and 03.820.352, lot 5919006

Distribution Pattern:

US distribution to TX and LA

Voluntary or Mandated:

Voluntary: Firm initiated