Recalls / —
—#122920
Product
3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
- FDA product code
- HWC — Screw, Fixation, Bone
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K110592
- Affected lot / code info
- All lots of parts 09.213.022S - 09.213.070S, and 09.223.032S- 09.223.090S.
Why it was recalled
All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.
Root cause (FDA determination)
Labeling False and Misleading
Action the firm took
Synthes sent an Urgent Notice: Medical Device Recall letter to Sales Reps and End Users on July 22, 2013. The letter identified the affect product, problem and actions to be taken. For questions call the Recall center at 610-719-5450.
Recalling firm
- Firm
- Synthes USA HQ, Inc.
- Address
- 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417
Distribution
- Distribution pattern
- Worldwide Distribution - USA (nationwide) and internationally to Canada.
Timeline
- Recall initiated
- 2013-07-22
- Posted by FDA
- 2013-11-26
- Terminated
- 2016-08-18
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #122920. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.