I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions a...
Reason for Recall / Hazard
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Product Description & Identification
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.
Affected Products
I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article numbers. 1. Distal Tubular Plate; Article Numbers: 21602-3, 21602-4, 21602-5, 21602-6, 21602-7, 21602-8, 21603-3, 21603-4, 21603-5, 21603-6, 21603-7, 21603-8. 2. Fibula Plate 3.5mm; Article Numbers: 21225-4, 21225-6, 21225-8, 21225-10, 21225-12, 21226-4, 21226-6, 21226-8, 21226-10, 21226-12. 3. Universal Tubular Plate; Article Numbers: 21601-5, 21601-6, 21601-7, 21601-8, 21601-10, 21601-12, 21601-14, 21601-16.
Additional Source Details
| Field | Value |
|---|---|
| City | Lasnitzhohe |
| Event id | 98341 |
| Address 1 | Autal 28 |
| Code info | 1. Article Number (Lot Numbers): 21602-3 (643/072330, 643/092310), 21602-4 (643/072301, 643/072308), 21602-5 (643/022417, 643/0650, 643/072309), 21602-6 (643/042305, 643/072333), 21602-7 (643/072332, 643/082305), 21602-8 (43/0405, 643/012305), 21603-3 (643/072331, 643/082306), 21603-4 (643/102214, 643/102206, 643/072302, 643/022313, 643/032310), 21603-5 (643/072335, 643/122308), 21603-6 (643/022309, 643/072305, 643/072311, 643/122309), 21603-7 (643/072337, 643/082313), 21603-8 (643/072312, 643/122204). 2. Article Number (Lot Numbers): 21225-4 (768/20894, 26/F65041, 26/F66149, 679/092305, 679/022430, 26/F705141, 26/F72362, 26/F73634), 21225-6 (768/20895, 768/20039, 26/F65042, 26/F66150, 26/F66499, 679/092321, 26/F705161, 679/062459, 26/F70516, 26/F73635), 21225-8 (768/20896, 26/F65635, 26/F66500, 26/F70515), 21225-10 (26/F66497), 21225-12 (26/F66498, 679/012438), 21226-4 (26/F65043, 26/F66152, 26/F66501, 26/F70521, 26/F705211, 679/012412, 679/062306, 679/092306, 768/20897, 768/208978... [TRUNCATED] |
| Postal code | N/A |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 869 units |
| Reason for recall | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260123 |
| Initial firm notification | |
| Center classification date | 20260320 |
Overview
- Recalling FirmI.T.S. GmbH
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the states of AL, AZ, BVI, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, OH, OK, PA, SC, TX, USVI, WV, W.