—#146323

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 correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the Ti6 Internal Fixation System.

FDA product code: HRS — Plate, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Lot UP15H2, Lot UP09D3, Lot UP07E2

Why it was 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

Root cause (FDA determination)

Process design

Action the firm took

The firm, Integra Lifesciences, sent an "Urgent: Voluntary Medical Device Recall" letter dated 5/10/16 to affected consignees/customers via traceable courier service on 5/10/16. The letter describes the product, problem and actions to be taken. The customers were instructed to stop using and distributing product immediately; complete and return the Recall Acknowledgement and Return Form via fax to 1-609-275-9445 or email to FCA2@integralife.com, even if you do not have any of the product. Should you have any questions, please contact Customer Service at 1-866-854-8300.

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 311 Enterprise Dr, Plainsboro, New Jersey 08536-3344

Distribution

Distribution pattern: US Distribution to states of: CO, FL, IL, MI, NJ, NY, SC, TX, and VA.

Timeline

Recall initiated: 2016-05-10
Terminated: 2016-12-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #146323. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.