ORTHOPEDIATRICS CANADA ULC FDA Inspection Record
ORTHOPEDIATRICS CANADA ULC is an FDA-registered facility (FEI 3000327445) located in Laval Quebec, CA. RegDataLab tracks 3 FDA inspections and 1 compliance action at this facility.
What FDA found at this site
- Latest inspection
- Mar 1, 2018: Voluntary Action Indicated (VAI)
- Inspections on record
- 3 (2 OAI, 1 VAI)
- Last OAI inspection
- Jul 25, 2013
- Warning letters
- 1 listed by FDA for this FEI, latest Oct 26, 2010
- Recalls as the recalling firm
- 10, latest Jul 4, 2024
- Import refusals
- 2
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 1, 2018 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures - Acceptance activities (21 CFR 820.80(a)) Lack of or inadequate procedures (21 CFR 820.100(a)) Process control procedures, Lack of or inadequate procedures (21 CFR 820.70(a)) Production and Process Change Procedures, lack of or Inad. (21 CFR 820.70(b)) and 1 more |
| Jul 25, 2013 | Official Action Indicated (OAI) | Procedures not adequately established or maintained (21 CFR 820.40) Lack of or inadequate procedures (21 CFR 820.100(a)) Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) Justification for not reporting (21 CFR 806.20(b)(4)) |
| Mar 31, 2010 | Official Action Indicated (OAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Jul 4, 2024 | Class II | Z-2941-2024 | FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM System During the assembly of the FRT250 cartridge assembly, an incorrect component was used. Specifically, the FRT240-HEX (2) was used instead of… |
| Apr 3, 2020 | Class III | Z-2038-2020 | Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM)… The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label. |
| Oct 2, 2019 | Class II | Z-0270-2020 | SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic… There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out. |
| May 29, 2019 | Class II | Z-2278-2019 | SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM)… Handle could jam with the Driver due to the detachment of an internal Connector Ring. |
| Oct 20, 2015 | Class II | Z-0324-2016 | SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free… SCFE Driver's threaded shaft broke close to the knob when a manual force was applied during the fixation of the screw. |
| Jun 15, 2015 | Class II | Z-1848-2015 | Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System… SCFE Drivers of the Free-Gliding SCFE Screw System are recalled because the handle of the instruments may detach from the shaft if high… |
| Apr 10, 2015 | Class II | Z-1546-2015 | Female Driver, Part number FDr101, instrument used for the insertion of the Fassier-Duval… The hexagonal tip of the Female Driver instrument for the Fassier-Duval IM Telescopic System is 0.06 mm under the specifications. This may… |
| Feb 20, 2015 | Class II | Z-1362-2015 | GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number… Failures of the 4.8mm of the GAP Endo-Exo Medullary System have been identified at the level of the distal cortical screw holes. Failures… |
| Mar 5, 2014 | Class II | Z-1472-2014 | Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant. Catalogue… The outer package label contained the incorrect length of the device. There is a label on the outer package and an additional label on the… |
| Feb 7, 2014 | Class II | Z-1448-2014 | Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part… The Male Components in this lot are made of material with lower strength than manufacturing specifications. |
FDA record score
6 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
13 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall Z-2941-2024, this FEI as the recalling firm | Jul 4, 2024 | 4 x 0.6 | 2.4 |
| Inspection classified VAI | Mar 1, 2018 | 6 x 0.25 | 1.5 |
| Class II recall Z-0270-2020, this FEI as the recalling firm | Oct 2, 2019 | 4 x 0.25 | 1 |
| Class II recall Z-2278-2019, this FEI as the recalling firm | May 29, 2019 | 4 x 0.25 | 1 |
| Class II recall Z-0324-2016, this FEI as the recalling firm | Oct 20, 2015 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1848-2015, this FEI as the recalling firm | Jun 15, 2015 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1546-2015, this FEI as the recalling firm | Apr 10, 2015 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1362-2015, this FEI as the recalling firm | Feb 20, 2015 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1472-2014, this FEI as the recalling firm | Mar 5, 2014 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1448-2014, this FEI as the recalling firm | Feb 7, 2014 | 10 years or older, so it adds no points | 0 |
| Inspection classified OAI | Jul 25, 2013 | 10 years or older, so it adds no points | 0 |
| Warning letter on FDA's dashboard, which does not show close-outs | Oct 26, 2010 | 10 years or older, so it adds no points | 0 |
| Inspection classified OAI | Mar 31, 2010 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 15, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
Reviewing ORTHOPEDIATRICS CANADA ULC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Or check ORTHOPEDIATRICS CANADA ULC yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Facility details
- Company
- ORTHOPEDIATRICS CANADA ULC
- Location
- Laval Quebec (CA)
- Source
- device