Recalls / —
—#122356
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.
- FDA product code
- HTW — Bit, Drill
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- 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
Why it was recalled
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.
Root cause (FDA determination)
Device Design
Action the firm took
Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory, immediately remove the affected product and return to Credit/Returns, Synthes. For questions call 610-719-5450.
Recalling firm
- Firm
- Synthes USA HQ, Inc.
- Address
- 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417
Distribution
- Distribution pattern
- USA Nationwide Distribution
Timeline
- Recall initiated
- 2013-07-31
- Posted by FDA
- 2013-11-27
- Terminated
- 2015-06-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #122356. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.