Recall Z-0404-2014— Synthes (USA) Products LLC
Class II · Terminated
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2013-10-14, terminated 2015-08-18. It names one FDA 510(k) clearance: K111667. Product: Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic fractures, and tibial malunions and non-unions.. Reason: Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar..
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-14
- Terminated
- 2015-08-18
- Firm location
- West Chester, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic fractures, and tibial malunions and non-unions.
Reason for recall
Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar.
Data sourced from openFDA. This site is unofficial and independent of the FDA.