PRODISC Orthopedic Manual Surgical Instrument, strut used in spinal surgery. Part numbers 03.820.350 and 03.820.352. Use

FDA device recall Z-1383-2017 · posted 2017-02-27 · Terminated

Recall details

Recalling firm

Synthes (USA) Products LLC

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

LXH

Quantity affected

2 units

Distribution

US distribution to TX and LA

Date initiated

2017-01-31

Date posted

2017-02-27

Date terminated

2017-12-01

Location

West Chester, PA