Z-2835-2016Class II

FPS 35mm x 3.5 mm non-locking screw

Name: Z-2835-2016 FPS 35mm x 3.5 mm non-locking screw
Creator: Ortho Solutions Inc
Published: 2016-07-21
License: https://open.fda.gov/license/

Ortho Solutions Inc / initiated 2016-07-21 / Terminated / root cause: labeling and UDI

FDA source

Ortho Solutions Inc began a recall of FPS 35mm x 3.5 mm non-locking screw on 2016-07-21. FDA classified it as Class II and gives the reason as "Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2835-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-21
Posted: 2016-09-16
Terminated: 2016-10-12
Recalling firm: Ortho Solutions Inc
Product: FPS 35mm x 3.5 mm non-locking screw
Product code: HWC Screw, Fixation, Bone
Reason for recall: Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Ortho Solutions sent a "Field Safety Notice" letter dated July 21, 2016 to their affected customers. The letter identify the Solutions Business Development Manager will contact the customer to arrange for the isolation and removal of the unused product from their inventory. Replacement product will be provided. The customer was advised to passed on the "Field Safety Notice" to all who need to be aware within their organization and to any organization to which their have further distributed or transferred the affected screw. Upon removal of the affected device, customers are asked to please sign and return the "Field Safety Corrective Action Declaration Form", by which to confirm they have received the "Field Safety Notice" and that they declare that the required recall has been completed at their hospital. For further questions, call (201) 258-7305.
Quantity in commerce: 15
Distribution: US Distribution
Product codes and lots: Part number - OS326835 Lot number: 10100/269A12-68051

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2835-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2835-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-28	2016-09-16

Product code HWC

K111678Class IIOrtho Solutions Extremity Fixation Implants for OsteosysnthesisOrtho Solutions Limited / cleared 2012-02-07

China's FDA-registered implant bench is 151 establishments of 4,70415 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)