Reported Aug 21, 2013 · Terminated
Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid
SpineFrontier, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SpineFrontier, Inc. · 500 Cummings Ctr Ste 3500 · Beverly, MA · 01915-6516
Is this the product you have?
Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid
6 of 6 products
| # | Product as published |
|---|---|
| 1 | 12-60039A, 11-60042B, 11-60043B, 11-60045B, 11-60046C, 11-60045A, 11-60046A, 11-60053A |
| 2 | Invue Lid: SI70095A |
| 3 | S-Lift Lid: SI50070A |
| 4 | S-Lift Base: SI50067A |
| 5 | Arena-C Lid: 11-72013D, 11-72014D |
| 6 | Generics Lid: 12-99005A. System cases are designed to hold and secure all instrumentation to be used with a surgical system. |
- Lot codes and dates
7 of 7 products
Products covered by this recall Model / number Product as published 12-60039A11-60042B, 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. - Amount recalled
- 258 units (30 in distribution at the time of the recall)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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