—#119360

Product

Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.

FDA product code: LRZ — Screwdriver, Surgical
Device class: Class 1
Medical specialty: General, Plastic Surgery
Affected lot / code info: The following lots of the cannulated screw driver (model number P/N 129733ND) were affected: D2ZG, D32L, D3HV, D3PG and E0U3. The following lots of the cannulated screwdriver tip (model number P/N 129735ND) were affected: D2ZQ and D3EC.

Why it was recalled

The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The firm sent recall notification letters to all consignees via traceable email or traceable fax on 02/01/13. The firm requested that the consignees fill out and return the Recall Acknowledgement and Return Form.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, and WA and the countries of Canada, Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Spain, Finland, France, Ireland, Israel, Italy, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, United Arab Republic, United Kingdom, and South Africa.

Timeline

Recall initiated: 2013-02-01
Posted by FDA: 2013-07-11
Terminated: 2013-07-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #119360. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.