PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle
Summary
The FDA issued a Class II for PERLA TL Lateral Connector Open - Product Usage: intended to be used with autogr by SPINEART SA. Reason: Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size..
Details
Source
Device Recall
External ID
Z-1975-2021
Action Date
2021-07-07
Status
Terminated
Category
device
Product 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
Lot/Code Info: 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
Quantity Affected: 44 units in the U.S.
Reason for Recall
Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
Distribution
U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided
Type: Voluntary: Firm initiated
Recall Initiated: 2021-04-09
Company
Plan-Les-Ouates, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 52 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SPINEART SA has 14 FDA actions in our database, including 5 recalls and 9 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SPINEART SA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SPINEART SA have FDA actions?
SPINEART SA has 14 FDA actions in our database, including 5 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1975-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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