Reported May 15, 2024 · Ongoing
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…
Spineart Sa
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SPINEART SA · Chemin Du Pre-Fleuri 3 · Plan-Les-Ouates, N/A · N/A
Is this the product you have?
- PERLA TL 25D SCREW REFTLF-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 spinedegenerative disc disease (painful degeneration of the disc), spondylolisthesis, trauma, spinal stenosis, deformities (i.e. scoliosis, kyphosis, or lordosis), tumor and failed previous fusion (pseudarthrosis)
- Lot codes and dates
10 of 10 products
Products covered by this recall Model / number Barcodes Product as published 25-S07640185345799TLF-DS 45 30-S07640185345805TLF-DS 45 35-S07640185345812TLF-DS 45 40-S07640185345829TLF-DS 45 45-S07640185345836TLF-DS 55 30-S07640185345850TLF-DS 55 35-S07640185345867TLF-DS 55 40-S07640185345874TLF-DS 55 45-S07640185345881TLF-DS 60 35-S07640305166082— - Amount recalled
- 242 systems
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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