—#153344

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

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Part numbers 03.820.350 Lot 5919005 and 03.820.352, lot 5919006

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Synthes (USA) Products LLC
Address: 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986

Distribution

Distribution pattern: US distribution to TX and LA

Timeline

Recall initiated: 2017-01-31
Posted by FDA: 2017-02-27
Terminated: 2017-12-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153344. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.