Z-1975-2021Class II

PERLA TL Lateral Connector Open -

Name: Z-1975-2021 PERLA TL Lateral Connector Open -
Creator: Spineart Sa
Published: 2021-04-09
License: https://open.fda.gov/license/

Spineart SA / initiated 2021-04-09 / Terminated / root cause: manufacturing process

FDA source

SPINEART SA began a recall of PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a... on 2021-04-09. FDA classified it as Class II and gives the reason as "Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1975-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-09
Posted: 2021-06-28
Terminated: 2022-09-29
Recalling firm: Spineart SA
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 posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mm
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 04/12/2021, the firm sent an email to its US Distribution Center and a follow-up "URGENT: MEDICAL DEVICE RECALL" letter (dated April 14, 2021) TO inform customers that the recall was being initiated due to an external labelling error where the external labels were mixed-up for two batches and could lead to confusion for the hospital staff and induce a minimal surgery delay. Customers are instructed to: 1. Immediately review their inventory and quarantine concerned products if any. 2. If they may have further distributed this product; please identify concerned customers and notify them at once of this product recall by using this document. 3. Collect and quarantine all products. 4. Sent back all products with the enclosed Response Form to Spineart Geneva (Chemin du Pr Fleuri 3, 1228 Plan-les-Ouates, Switzerland). E-mail: [email protected]. 5. All returned products will be exchanged with batches already available in our warehouse.
Quantity in commerce: 44 units in the U.S.
Distribution: U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1975-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1975-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-07	2021-06-28

Product code NKB

K193396Class IIPERLA® TL posterior osteosynthesis systemSpineart / cleared 2020-02-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)