InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments

FDA device recall Z-1666-2013 · posted 2013-07-05 · Terminated

Recall details

Recalling firm

SpineFrontier, Inc.

Reason for recall

Potential for set screw to be come deformed.

Action taken

Spine Frontier sent an Urgent Advisory Notice letter dated May 30, 2013 to all affected consignees. The letter identified the affected product. problem and actions to be taken. The letter informed consignees that a correction was implemented for InSpan Inserters. Consignees were instructed to remove parts from the field immediately for modification and that replacement Inserters will be shipped upon receipt of completed acknowledgement form and RMA request for part return. For questions call 978-232-3990.

Root cause

Device Design

Status

Terminated

Product code

HXX

Quantity affected

61 individual inserter assemblies

Distribution

Worldwide Distribution - USA Nationwide: in the states of: FL, CO, VA, KS, TX, OH, TN, OK, CA, IL, MO, MN, Wash DC, including PR and the countries of Dominican Republic, Medico, Panama

Date initiated

2013-05-07

Date posted

2013-07-05

Date terminated

2016-01-11

Location

Beverly, MA