Recall Z-1004-2019— Ossur Americas
Class II · Terminated
Class II FDA medical device recall by Ossur Americas, initiated 2018-06-21, terminated 2020-09-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL; 545100L/ LIL ANGEL VEST P2 LAMBSWOOL; 545100S/ LIL ANGEL VEST P2 SORBATEX; 545150K/ LIL ANGEL VEST P3 KODEL; 545150L/ LIL ANGEL VEST P3 LAMBSWOOL; 545150S/ LIL ANGEL VEST P3 SORBATEX. Reason: Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin..
- Recalling firm
- Ossur Americas
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-06-21
- Terminated
- 2020-09-04
- Firm location
- Foothill Ranch, CA, United States
Product description
Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KODEL; 545100L/ LIL ANGEL VEST P2 LAMBSWOOL; 545100S/ LIL ANGEL VEST P2 SORBATEX; 545150K/ LIL ANGEL VEST P3 KODEL; 545150L/ LIL ANGEL VEST P3 LAMBSWOOL; 545150S/ LIL ANGEL VEST P3 SORBATEX
Reason for recall
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Data sourced from openFDA. This site is unofficial and independent of the FDA.