Ortho Solutions Inc: Medical Device Recall in 2016 - (Recall #: Z-2835-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

FPS 35mm x 3.5 mm non-locking screw

Product Classification:

Class II

Date Initiated: July 21, 2016

Date Posted: September 28, 2016

Recall Number: Z-2835-2016

Event ID: 74849

Reason for Recall:

Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.

Status: Terminated

Product Quantity: 15

Code Information:

Part number - OS326835 Lot number: 10100/269A12-68051

Distribution Pattern:

US Distribution

Voluntary or Mandated:

Voluntary: Firm initiated