Z-1383-2017Class II

PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and...

Name: Z-1383-2017 PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and...
Creator: Synthes (USA) Products LLC
Published: 2017-01-31
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2017-01-31 / Terminated / root cause: labeling and UDI

FDA source

Synthes (USA) Products LLC began a recall of 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... on 2017-01-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1383-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-31
Posted: 2017-02-27
Terminated: 2017-12-01
Recalling firm: Synthes (USA) Products LLC
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
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: DePuy Synthes mailed an Urgent Notice to customers affected by the issue on 02/13/2017. The reason for the recall was explained, risks associated with the issue were identified, and actions to be taken were addressed. Customers were asked to complete the enclosed Verification form and mail it back to obtain a Return Authorization Number for the product's return. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant. For questions regarding this recall call 800-479-6329.
Quantity in commerce: 2 units
Distribution: US distribution to TX and LA
Product codes and lots: Part numbers 03.820.350 Lot 5919005 and 03.820.352, lot 5919006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1383-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1383-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-08	2017-02-28

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)