I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System ...
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. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.
Affected Products
I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions and corresponding article numbers. 1. I.T.S. DUL (Distal Ulna Locking) System, Distal Ulna Plate; Article Numbers: 21232-3, 21232-4, 21232-6, 21233-3, 21233-4, 21233-6, 21234-4, 21235-4. 2. I.T.S. UOL (Ulna Osteotomy Locking) System, Ulna Osteotomy Plate; Article Numbers: 21231-6. 3. UOL (Ulna Osteotomy Locking) System, Cancellous Screw, Locking; Article Numbers: 37302-18, 37302-20.
Additional Source Details
| Field | Value |
|---|---|
| City | Lasnitzhohe |
| Event id | 98341 |
| Address 1 | Autal 28 |
| Code info | 1. Article Number (Lot Numbers): 21232-3 (26/F65636), 21232-4 (26/F61722, 26/F65637), 21232-6 (26/F62564, 26/F65638), 21233-3 (26/F65639), 21233-4 (26/F65640), 21233-6 (26/F61723, 26/F65046), 21234-4 (26/F65641, 26/F66504), 21235-4 (26/F65642, 26/F67810). 2. Article Number (Lot Numbers): 21231-6 (643/012301, 643/022310, 643/032308, 643/0630, 643/0657, 643/102402, 643/122301). 3. Article Number (Lot Numbers): 37302-18 (18/636447), 37302-20 (18/802189). |
| Postal code | N/A |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 120 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.