Recall Register

Food, drugs, devices › Firms

SPINEART SA

FDA recalling firm · 6 enforcement events · 13 product records · 2017–2025 · N/A

SPINEART SA has 6 FDA enforcement events on this register (13 product records) between 2017 and 2025: 6 device; the busiest year was 2017 with 1.

0% of its events are Class I; the most common class is Class II (5). 3 events are listed as ongoing; the recalling firm's address is in N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
30 Jun 2025Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 65 40-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW Component: NoDeviceClass II2Ongoing
15 Mar 2024PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 40-S TLF-DS 55 45-S TLF-DS 65 35-S TLF-DS 65 40-S TLF-DS 65 45-S TLF-DS 65 50-S The PERLA¿ TL system is intended to provide immobilization and stabilization of spinal segments in…DeviceClass II1Ongoing
16 Mar 2023JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE SMALL, REF: JLT-PL 02 08-S, JLT-PL 02 10-S, JLT-PL 02 12-S, JLT-PL 02 14-S, JLT-PL 02 16-S; JULIET Ti LL, LATERAL LUMBAR TI-LIFE PLATE LARGE, REF: JLT-PL 04 08-S, JLT-PL 04 10-S, JLT-PL 04 12-S, JLT-PL 04 14-S, JLT-PL 04 16-S, JLT-PL 04 18-SDeviceClass II1Ongoing
9 Apr 2021PERLA 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, 30mmDeviceClass II1Terminated
5 Feb 2019Intersomatic JULIET Ti OL cage. For use in orthopedic spinal proceduresDeviceClass III1Terminated
27 Nov 2017TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF TRY-PS-40 12-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the…DeviceClass II7Terminated

By type and class

Device6
Class II5
Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

17
18
19
20
21
22
23
24
25
26
Enforcement events for SPINEART SA by year initiated.

Questions and answers

How many FDA recalls has SPINEART SA had?

6 enforcement events (13 product records) on this register, 2017–2025: 6 device.

Are any SPINEART SA recalls ongoing?

3 events are listed as ongoing in the current openFDA export.

What class are SPINEART SA recalls?

5 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.