Z-2849-2016Class II

TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is...

Name: Z-2849-2016 TriMed Semi-Tubular Plate, 10-Hole, Model No. SMTP-10 Contoured plate with offset screw holes. The plate is...
Creator: Trimed Inc
Published: 2016-08-29
License: https://open.fda.gov/license/

Trimed Inc / initiated 2016-08-29 / Terminated / root cause: design

FDA source

Trimed Inc began a recall of 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... on 2016-08-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2849-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-29
Posted: 2016-09-20
Terminated: 2016-11-01
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.
Product code: HRS Plate, Fixation, Bone
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.
Root cause tag: design
FDA 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: [email protected]. Customers with questions are instructed to contact Director of Operations at (800) 633-7221, [email protected], M-F, 9am-5pm, Pacific Standard.
Quantity in commerce: 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.
Product codes and lots: Lot no. 06206

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2849-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2849-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-20

Product code HRS

K060041Class IITrimed Bone PlatesTriMed, Inc. / cleared 2006-02-07

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)