PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mm

Class I - Dangerous

🏥 Medical Devices Recalled: April 9, 2021 SPINEART SA Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
Reference Number/Product Description/Batch Number: -TLF-LC OP 15-S / PERLA TL Lateral Connector Open, 15mm / 5-2983 -TLF-LC OP 30-S / PERLA TL Lateral Connector Open, 30mm / 5-2993
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: SPINEART SA
Reason for Recall:: Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mm

Product Codes/Lot Numbers:

Reference Number/Product Description/Batch Number: -TLF-LC OP 15-S / PERLA TL Lateral Connector Open, 15mm / 5-2983 -TLF-LC OP 30-S / PERLA TL Lateral Connector Open, 30mm / 5-2993

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1975-2021

Related Recalls

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

SPINEART SA

Class I - Dangerous

Cannulated fenestrated polyaxial screws may be incorrectly labeled

Jun 30, 2025 Other Medical Devices Nationwide View Details →

Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: No

SPINEART SA

Class I - Dangerous

Cannulated fenestrated polyaxial screws may be incorrectly labeled

Jun 30, 2025 Other Medical Devices Nationwide View Details →

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).

SPINEART SA

Class I - Dangerous

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

Mar 15, 2024 Infusion Pumps Nationwide View Details →