Device product
INTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
Z-0943-2013
Product summary
- Event
- Event 64342
- Status
- Terminated
- Classification
- Class II
- Quantity
- 69 units
- Official record key
device-enforcement:Z-0943-2013
Official wording
Reason: 75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.
Code information: Batch Number 12KM01206
Distribution pattern: Worldwide Distribution - USA including NM, TN, TX, NC, CA, MI, KY, MA, NJ, OH, and HI. Internationally to Canada, United Arab Emirates, Mexico, Argentina, Japan, and Chile.
Derived failure modes
-
Unknown
75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.