FDA Medical Device Recalls (openFDA)
SPINEART SA: Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
- Recall number
- Z-2280-2025
- Recalling firm
- SPINEART SA
- Product
- Brand Name: PERLA TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
- Status
- Open, Classified
- Initiated
- 2025-06-30
- Posted
- 2025-08-08
- Terminated
- not on file
- Reason
- Cannulated fenestrated polyaxial screws may be incorrectly labeled
- Root cause
- Labeling Change Control
- Action
- On July 4, 2025, Spineart SA, issued a Urgent: Medical Device Recall Notification to affected consignees via E-Mail. On July 10, 2025, Spineart SA issued a revised notification to provide additional information. On July 16,2025, Spineart expanded the recall to include an additional product and lot. Spineart SA ask consignees to take the following steps: (1) Please acknowledge receipt of this letter by emailing to orders@spineart.us (2) Please discontinue use and return any product on hand that is listed in the Product and Distribution Information section of this letter to: Spineart U.S.A. 23332 Mill Creek Drive Suite 150 Laguna Hills, CA. 92653 (3) You may have further distributed this product; please identify concerned customers and notify them at once of this product recall by using this document. (4) Surgeons/physicians should closely monitor patients that have been implanted with these potential non-conforming screws.
- Quantity
- 0
- Distribution
- US Nationwide distribution in the states of Florida , Kentucky, California.
- Lot, serial or model codes
- Lot Code: Lot number 8-4266 GTIN 07640305160493
- 510(k) numbers
- ["K203506"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3007728266
- Firm city
- Plan-Les-Ouates
- Firm state
- not on file
- Firm country
- Switzerland
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