Recall Z-0323-2016— Synthes (USA) Products LLC
Class II · Terminated
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2015-11-02, terminated 2016-07-15. It names 6 FDA 510(k) clearances: K103243, K102694, K063049 and 3 more. Product: 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.. Reason: It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System)..
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-02
- Terminated
- 2016-07-15
- Firm location
- West Chester, PA, United States
510(k) clearances named in this recall
6 on FDA's record- K103243 — 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM
- K102694 — 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES
- K063049 — SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM
- K050110 — SYNTHES (USA) LCP MODULAR FOOT PLATES
- K040588 — SYNTHES (USA) 2.4 MM LCP WRIST PLATE
- K012114 — SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM
K-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
2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
Reason for recall
It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System).
Data sourced from openFDA. This site is unofficial and independent of the FDA.