Reported Jul 7, 2021 · Terminated
PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle…
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
- Lateral Connector Open - Product Usageintended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach
- Models
PERLA TL Lateral Connector Open15mm PERLA TL Lateral Connector Open30mm
- Lot codes and dates
- 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
- Amount recalled
- 44 units in the U.S.
Where it was sold
Why it was recalled
Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
This product could cause temporary or reversible health problems — stop using it.
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