Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 1
FDA device recall Z-1685-2013 · posted 2013-07-11 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- The firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LRZ
- Quantity affected
- 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
- Date initiated
- 2013-02-01
- Date posted
- 2013-07-11
- Date terminated
- 2013-07-25
- Location
- Plainsboro, NJ
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