Recall Z-0406-2014— Synthes (USA) Products LLC
Class II · Terminated
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2013-07-30, terminated 2015-08-17. It names one FDA 510(k) clearance: K001941. Product: Synthes 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.. Reason: A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate..
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-07-30
- Terminated
- 2015-08-17
- 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 2.4 mm LC-DCP Plate 6 Holes/51mm Product Usage: Intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.
Reason for recall
A complaint was reported regarding a screw being found in a package labeled for 2.4 mm LC-DCP Plate.
Data sourced from openFDA. This site is unofficial and independent of the FDA.