Recalls / —
—#140316
Product
Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
- FDA product code
- LXH — Orthopedic Manual Surgical Instrument
- Device class
- Class 1
- Medical specialty
- Orthopedic
- Affected lot / code info
- Part Numbers: 03.120.005 03.120.004 03.120.002 03.120.001 with Lot Numbers: 1780076; 1797331; 1829300 1789754; 1802319; 1810706; 1810707; 5704446 1780074; 1829294; 1829296 1789751; 1802318; 1810704; 1810705; 1828749; 1879604
Why it was recalled
Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm LCP Proximal Tibia Plates are not able to be secured to the subsequent versions of these devices as intended.
Root cause (FDA determination)
Device Design
Action the firm took
An urgent notice of medical device recall, dated September 14, 2015, was sent to end users and sales consultants to alert them to the issue and potential risks. Return of the completed response form and the affected devide was also requested.
Recalling firm
- Firm
- Synthes (USA) Products LLC
- Address
- 1301 Goshen Pkwy, West Chester, Pennsylvania 19380-5986
Distribution
- Distribution pattern
- Nationally
Timeline
- Recall initiated
- 2015-09-14
- Posted by FDA
- 2015-10-05
- Terminated
- 2016-07-15
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #140316. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.