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Terminated

Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A; Invue Lid: SI70095A; S-Lift Lid: SI50070A; S-Lift Base: SI50067A; Arena-C Lid: 11-72013D, 11-72014D; Generics Lid: 12-99005A. System cases are designed to hold and secure all instrumentation to be used with a surgical system.

FDA Recall Z-1958-2013 · Posted 2013-08-13

Recalling FirmSpineFrontier, Inc.
Recall StatusTerminated
Product CodeFSM
Date Initiated2013-04-22
Date Terminated2015-11-06
Product Quantity258 units (30 in distribution at the time of the recall)

Reason for Recall

Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be either delaminating or running off from the substrate after repeated washing and sterilization cycles.

Firm Action

On 2/15/2013, SpineFrontier emailed distributors informing them that they needed specific parts returned to work towards completing the conversion of product graphics.

Root Cause

Labeling design

Distribution Pattern

Worldwide Distribution-USA including the states of FL, OH, MA, and TX, and the countries of Mexico, and Dominican Republic.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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