Date Initiated by Firm |
March 15, 2024 |
Date Posted |
May 03, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1758-2024 |
Recall Event ID |
94257 |
510(K)Number |
K193396
|
Product Classification |
Thoracolumbosacral pedicle screw system - Product Code NKB
|
Product |
PERLA TL 25D SCREW REF:
TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 40-S TLF-DS 55 45-S TLF-DS 65 35-S TLF-DS 65 40-S TLF-DS 65 45-S TLF-DS 65 50-S
The PERLA¿ TL system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease (painful degeneration of the disc), spondylolisthesis, trauma, spinal stenosis, deformities (i.e. scoliosis, kyphosis, or lordosis), tumor and failed previous fusion (pseudarthrosis). |
Code Information |
Model Numbers/Lot-Batch Numbers:
TLF-DS 45 25-S 7-4407
TLF-DS 45 25-S 7-6207
TLF-DS 45 30-S 7-4244
TLF-DS 45 30-S 7-6226
TLF-DS 45 35-S 7-4242
TLF-DS 45 35-S 7-5470
TLF-DS 45 35-S 7-6684
TLF-DS 45 40-S 7-6232
TLF-DS 45 45-S 7-5474
TLF-DS 45 45-S 7-6874
TLF-DS 55 30-S 7-4409
TLF-DS 55 30-S 7-4695
TLF-DS 55 30-S 7-4965
TLF-DS 55 35-S 7-4413
TLF-DS 55 35-S 7-6455
TLF-DS 55 40-S 7-4415
TLF-DS 55 40-S 7-4417
TLF-DS 55 45-S 7-4411
TLF-DS 55 45-S 7-5055
TLF-DS 55 45-S 7-6087
TLF-DS 55 45-S 7-6459
TLF-DS 65 35-S 7-4405
TLF-DS 65 35-S 7-6230
TLF-DS 65 35-S 7-6461
TLF-DS 65 35-S 7-6882
TLF-DS 65 40-S 7-4248
TLF-DS 65 40-S 7-4250
TLF-DS 65 40-S 7-5480
TLF-DS 65 40-S 7-6228
TLF-DS 65 40-S 7-6554
TLF-DS 65 40-S 7-6740
TLF-DS 65 45-S 7-4582
TLF-DS 65 45-S 7-5484
TLF-DS 65 45-S 7-5808
TLF-DS 65 45-S 7-6668
TLF-DS 65 45-S 7-6742
TLF-DS 65 45-S 7-7299
TLF-DS 65 50-S 7-5488
TLF-DS 65 50-S 7-9264
UDI-DI for associated Model Numbers:
TLF-DS 45 25-S 07640185345799
TLF-DS 45 30-S 07640185345805
TLF-DS 45 35-S 07640185345812
TLF-DS 45 40-S 07640185345829
TLF-DS 45 45-S 07640185345836
TLF-DS 55 30-S 07640185345850
TLF-DS 55 35-S 07640185345867
TLF-DS 55 40-S 07640185345874
TLF-DS 55 45-S 07640185345881
TLF-DS 60 35-S 07640305166082
|
Recalling Firm/ Manufacturer |
SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland
|
Manufacturer Reason for Recall |
Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either:
1. The setscrew is not tightened to torque
2. The setscrew is tightened to torque but position askew
|
FDA Determined Cause 2 |
Process design |
Action |
On 03/15/2024, the firm called and then emailed one distributor, Spineart USA, Inc.(U.S. Distribution Center) to quarantine products in stock and identify locations of products already distributed.
the firm's U.S. Distribution Center sent an "URGENT: MEDICAL DEVICE RECALL" letter on 04/08/2024 via email to customers to inform them that
Customers have been instructed as follow:
1. Immediately review your inventory and quarantine concerned products if any.
2. You may have further distributed this product; please identify concerned customers and notify them at once of this product recall by using this document.
3. Collect and quarantine all products.
4. Sent back all products with the enclosed Response Form to Spineart warehouse SPINEART SLI, ATTN LAURE-ALLISON VERBOUX,
80 RUE DOUGLAS ENGELBART
FR-74160 ST JULIEN EN GENEVOIS
E-mail: regulatory@spineart.com
|
Quantity in Commerce |
242 systems |
Distribution |
U.S. Nationwide distribution in the states of CA, and KY. Not provided due to affected devices were manufactured O.U.S. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database |
510(K)s with Product Code = NKB and Original Applicant = Spineart
|