FDA Medical Device Recalls (openFDA)
Trimed Inc: 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.
- Recall number
- Z-2849-2016
- Recalling firm
- Trimed Inc
- 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.
- Status
- Terminated
- Initiated
- 2016-08-29
- Posted
- not on file
- Terminated
- 2016-11-01
- 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.
- Root cause
- Device Design
- Action
- 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.
- 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.
- Lot, serial or model codes
- Lot no. 06206
- 510(k) numbers
- ["K060041"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3001236812
- Firm city
- Santa Clarita
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28