FDA Medical Device Recalls (openFDA)
Ortho Solutions Inc: FPS 35mm x 3.5 mm non-locking screw
- Recall number
- Z-2835-2016
- Recalling firm
- Ortho Solutions Inc
- Product
- FPS 35mm x 3.5 mm non-locking screw
- Status
- Terminated
- Initiated
- 2016-07-21
- Posted
- not on file
- Terminated
- 2016-10-12
- Reason
- Mislabeling of a single batch of FPS 3.5 x 35 mm Locking Screw as being Non-Locking Screws.
- 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
- 15
- Distribution
- US Distribution
- Lot, serial or model codes
- Part number - OS326835 Lot number: 10100/269A12-68051
- 510(k) numbers
- ["K111678"]
- PMA numbers
- not on file
- Product code
- HWC
- Firm FEI
- 3022270316
- Firm city
- Mahwah
- Firm state
- NJ
- 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
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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