TS Series Depth Gauge for Integra Ti6 Internal Fixation recall
TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the physician to determine the…
Why was TS Series Depth Gauge for Integra Ti6 Internal Fixation recalled?
As a result of an internal investigation of a non-conformance it has been determined: 1) Depth Gauges from Lot UP15H2 exceed the overall length specification requirements. 2) Depth Gauges from prior lot numbers manufactured before Integra acquired the product line reflect an incorrect number for the first mm depth marking on the gauge. The number should be 4, it is 6. 3) The space / holder
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot UP15H2, Lot UP09D3, Lot UP07E2
- Product
- TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws The FS2030 Depth Gauge is used by the physician to determine the…
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 71 units
- Distribution
- US Distribution to states of: CO, FL, IL, MI, NJ, NY, SC, TX, and VA.
- Recall date
- June 22, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)