Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C); Inspan Lid: 12-60039A, 11-60042B, 11-60043B, 11-60
FDA device recall Z-1958-2013 · posted 2013-08-13 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FSM
- Quantity affected
- 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.
- Date initiated
- 2013-04-22
- Date posted
- 2013-08-13
- Date terminated
- 2015-11-06
- Location
- Beverly, MA
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