Recall Z-2849-2016
Trimed Inc · initiated August 29, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot no. 06206
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.
FDA-determined cause: Device Design
Action taken
The firm, TriMed, sent a "Medical Device Recall Notification" Letter dated 8/29/16 to customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory and quarantine the product subject to this recall; notify your customers at once of this product recall; discontinue use; return product, and complete and return the enclosed MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form as soon as possible by Fax to: 1-661-254-8485 or email to: davidmedoff@trimedortho.com. Customers with questions are instructed to contact Director of Operations at (800) 633-7221, davidmedoff@trimedortho.com, M-F, 9am-5pm, Pacific Standard.
Details
- Recall number
- Z-2849-2016
- Initiated
- August 29, 2016
- Terminated
- November 1, 2016
- Product code
- HRS – Plate, Fixation, Bone
- Quantity
- 30 units
- Distribution
- Worldwide Distribution-US (nationwide) including states of: Alabama, Florida, Indiana, Connecticut, California, Wisconsin, Missouri, Florida, Hawaii; and countries of: Sweden and South Africa.
- Recalling firm
- Trimed Inc, Santa Clarita, CA