Skip to content
Recall Observatory FDA recall evidence

Device product

Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.

Z-0408-2014

July 31, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
Event
Event 66412
Status
Terminated
Classification
Class II
Quantity
166
Official record key
device-enforcement:Z-0408-2014

Official wording

Reason: There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.

Code information: Parts 03.207.001 and 03.207.008 with lot numbers: Part # Lot # 03.207.001 PE00376 PE00439 PE01391 PE01329 PE01412 PE00504 03.207.008 PE00440 PE00377 PE00513 PE01475 PE01691

Distribution pattern: USA Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.