Case Lid and Base — Class II medical device recall Z-1958-2013
Terminated recall by SpineFrontier, Inc., reported 2013-08-21, distributed in FL, MA, OH, TX. Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be
| Recall number | Z-1958-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SpineFrontier, Inc., Beverly, MA, United States |
| Recall initiated | 2013-04-22 |
| Classified | 2013-08-13 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2015-11-06 |
| Distributed | FL, MA, OH, TX |
| Countries outside the US | DO, MX |
| Quantity | 258 units |
| Lot numbers | 011498, 011649, 011969-001, 011969-002, 11-72013D, 11-72014D, 6250.009-R, 7183.007R, 7197.024, 7201.007, 7201.008, 8372.001, SI50070A |
| Model numbers | 11-60042B, 11-60043B, 11-60045A, 11-60045B, 11-60046A, 11-60046C, 11-60053A, 12-60039A |
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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.