Recall Z-2291-2021 ยท QHE Shoulder Arthroplasty Implantation System
Tornier S.A.S.
The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm Eccentric LOW (1.5) Material PyC/CoCr, b) Catalog # DWH041 - Diameter 41 m m Height 15 mm Eccentric LOW (1.5) Material PyC/CoCr, c) Catalog # DWH043 - Diameter 43 mm Height 16 mm Eccentric LOW (1.5) Material PyC/CoCr, d) Catalog # DWH046 - Diameter 46 mm Height
| Date | Jun 25, 2021 |
| Status | Open, Classified |
| Reason | Potential patient exposure to the graphite substrate. |
| Root cause | Device Design |
| Action | On June 25, 2021 Tornier sent the following notification by letter: With regards to cases where this product has already been implanted, we suggest that physicians check for the potential presence of metallic bodies in the shoulder joint and adapt patient monitoring, as appropriate, when metallic bodies are present. Otherwise, we suggest that physicians continue the monitoring of patients per their standard clinical protocols. Actions needed 1. Please circulate this Field Safety Notice to all surgeons using AEQUALIS" PYROCARBON Humeral Head Implant 2. Maintain awareness of this communicati |
| Quantity | 6631 units |
| Distribution | CA, CO, CT, FL, KS, LA, MD, MI, MN, MO, NC, OR, PA, TX and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.