Recall Z-2849-2016— Trimed Inc
Class II · Terminated
Class II FDA medical device recall by Trimed Inc, initiated 2016-08-29, terminated 2016-11-01. It names one FDA 510(k) clearance: K060041. Product: TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conformance with ASTM F138 or F139. The plate is used to fixation of long bone fractures. The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.. Reason: TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted..
- Recalling firm
- Trimed Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-29
- Terminated
- 2016-11-01
- Firm location
- Santa Clarita, CA, 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
TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is 103 mm in length, 1.3 mm thick and 9.6 mm wide. The part is made of surgical steel conformance with ASTM F138 or F139. The plate is used to fixation of long bone fractures. The TriMed Bone Plates are intended for use in the fixation of fractures to the Tibia, Fibula, Ulna, Radius and the Humerus.
Reason for recall
TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted.
Data sourced from openFDA. This site is unofficial and independent of the FDA.