FDA Medical Device Recalls (openFDA)
SpineFrontier, Inc.: 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.
- Recall number
- Z-1958-2013
- Recalling firm
- SpineFrontier, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2013-04-22
- Posted
- 2013-08-13
- Terminated
- 2015-11-06
- 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.
- Root cause
- Labeling design
- 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.
- Quantity
- 258 units (30 in distribution at the time of the recall)
- Distribution
- Worldwide Distribution-USA including the states of FL, OH, MA, and TX, and the countries of Mexico, and Dominican Republic.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSM
- Firm FEI
- 3005977257
- Firm city
- Beverly
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28