Recall Z-1685-2013 ยท LRZ Screwdriver, Surgical
Integra LifeSciences Corp.
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.
| Date | Jul 11, 2013 (initiated Feb 1, 2013) |
| Status | Terminated |
| Reason | The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery. |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 154 screwdrivers were distributed; 67 screwdriver tips were distributed. |
| Distribution | 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, Spa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.