Reported Apr 1, 2026 · Ongoing
FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding…
I.T.S. GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: I.T.S. GmbH · Autal 28 · Lasnitzhohe · N/A
Is this the product you have?
9 of 9 products
| # | Product as published |
|---|---|
| 1 | FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. |
| 2 | FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. |
| 3 | FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. |
| 4 | FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. |
| 5 | FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. |
| 6 | FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. |
| 7 | FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. |
| 8 | FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. |
| 9 | HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09. |
- Lot codes and dates
- 1
- Article Number (Lot Numbers)
75 of 75 codes
37303-10 (18/15172018/268729679/032432679/072268679/102237679/102307)37303-12 (18/570637679/032434679/072269679/102346679/112227)37303-14 (18/75109126/F66913679/012510679/062288679/102359679/112410)37303-16 (679/072263679/10224518/15184126/F6691418/33119318/543625679/012511679/042403679/102360)37303-18 (18/15194218/21046718/23141518/34119418/57263318/771093679/012512679/022507679/042404679/102248679/112319)37303-20 (18/15204318/21146818/35119518/57363418/70158518/781094679/022508679/042420679/112216679/112328)37303-22 (18/17170518/21246918/36119618/57463518/791095679/022509679/042417679/112224679/112340)37303-24 (18/57563918/74157226/F66915679/022510
- Article Number (Lot Numbers)
32271-10 (18/06194918/231167679/062351)32271-12 (18/04892726/F66235679/042215679/062342679/062405679/062489679/072271)32271-14 (18/04992818/23116526/F66140679/042210679/052340679/052518679/062471679/062490679/072267)32271-16 (18/23116418/31112526/F66141679/042216679/052519679/062315679/062483679/072272679/072401)32271-18 (18/06295026/F6555626/F66236679/032261679/062332679/072402)32271-20 (18/06395126/F66237679/052326)32271-22 (18/06495226/F65557679/032263679/062354)32271-24 (18/06595326/F65558679/062333)32271-26 (679/032265)32271-28 (26/F65559679/062357679/052520)32271-32 (26/F65561)32271-34 (26/F65562). 3
- Article Number (Lot Numbers)
37304-10 (18/63548626/F24799679/01241986/011176)37304-12 (18/06135218/52117218/521172118/57664318/630487679/012433679/092207679/122409)37304-14 (18/08136018/53117318/531173118/57764418/631488679/012434679/092208679/122410)37304-16 (18/54117418/57864518/632489679/012444679/092201679/122411)37304-18 (18/09202018/55117518/633490679/022403679/092202)37304-20 (18/01132018/56117618/634491679/012287679/012420679/08221786/483331)37304-22 (18/241273679/012288679/012421)37304-24 (18/02132118/571177679/012289679/012445). 4
- Article Number (Lot Numbers)21413-6 (26/F52124). 5
- Article Number (Lot Numbers)21431-ME (679/102045). 6
- Article Number (Lot Numbers)
21482 (679/092020)21483 (26/F55902). 7
- Article Number (Lot Numbers)
21421-5 (26/F65377679/092039). 8
- Article Number (Lot Numbers)
37241-10 (18/01216918/61010418/701013)37241-12 (18/23129518/767108)37241-14 (18/51101618/53739226/F24807679/012280)37241-16 (18/00534018/12110618/23138718/52101718/560517)37241-18 (18/23232818/531018679/07240886/311848)37241-20 (18/23338818/54102018/562519679/07241986/287847)37241-22 (18/06610918/23438918/55102126/F2459426/F24811)37241-24 (18/56102218/56452118/60811026/F24595)37241-26 (18/61111118/71102326/F2459626/F24813)37241-28 (18/61211218/72102418/81159726/F2459786/485508)37241-30 (18/01517218/61311318/73101926/F24598). 9
- Article Number (Lot Numbers)
21015-08 (00/0123-1200/0321-4300/0723-07)21015-09 (00/0123-13)
- Amount recalled
- 15,517 units
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
Why it was recalled
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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