PERLA TL Lateral Connector Open - Product Usage recall: Labeling Error
PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a…
Why was PERLA TL Lateral Connector Open - Product Usage recalled?
Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a…
- Recalling firm
- SPINEART SA
- Quantity
- 44 units in the U.S.
- Distribution
- U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided
- Recall date
- July 7, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)