Z-2849-2016 Class II Terminated
FDA device recall Z-2849-2016 was initiated by Trimed Inc on August 29, 2016 and is designated Class II. 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. The recall status is terminated (terminated November 1, 2016). Affected quantity: 30 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 28, 2016
- Initiation Date
- August 29, 2016
- Termination Date
- November 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 units
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.
Distribution Pattern
Worldwide Distribution-US (nationwide) including states of: Alabama, Florida, Indiana, Connecticut, California, Wisconsin, Missouri, Florida, Hawaii; and countries of: Sweden and South Africa.
Code Information
Lot no. 06206