FDA Medical Device Recalls (openFDA)
SPINEART SA: 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
- Recall number
- Z-1975-2021
- 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
- Status
- Terminated
- Initiated
- 2021-04-09
- Posted
- not on file
- Terminated
- 2022-09-29
- Reason
- Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.
- 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: regulatory@spineart.com. 5. All returned products will be exchanged with batches already available in our warehouse.
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- K193396
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3007728266
- Firm city
- Plan-Les-Ouates
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28