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 Recall Z-1383-2017 · Posted 2017-02-27
Advertisement
Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeLXH
Date Initiated2017-01-31
Date Terminated2017-12-01
Product Quantity2 units
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.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US distribution to TX and LA
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement