FDA Device recall Z-1958-2013
Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C)
- FDA Device
- Class II
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class II recall of Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C) by Spinefrontier, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1958-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-04-22 |
| Published | 2013-08-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Spinefrontier |
| Distribution | FL, MA, OH, TX |
Product
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.
Reason
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.
Identifiers
| code_info | Inspan Lid: Part Number: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A, Lot Nu…Inspan Lid: Part Number: 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A, Lot Numbers: 7197.024, 011649, 011498; Invue Lid: SI70095A, Lot Number: 6250.009-R; S-Lift Lid: SI50070A, Lot Number: 7201.008; S-Lift Base: SI50067A; Lot Numbers: 7183.007R, 7201.007; Arena-C Lid: 11-72013D, 11-72014D, Lot Numbers: 011969-001, 011969-002; Generics Lid: 12-99005A, Lot Number: 8372.001. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1958-2013%22
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