Recall Z-1072-2022 ยท KWI Prosthesis, Elbow, Hemi-, Radial, Polymer
Synthes (USA) Products LLC
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 24mm in length.
| Date | Apr 7, 2022 |
| Status | Open, Classified |
| Reason | DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis. |
| Root cause | Labeling Change Control |
| Action | DePuy Synthesis issued Urgent: MEDICAL DEVICE CORRECTION (Notification) on 4/14/22. Letter states reason for recall, health risk and action to take: " Download and review the updated version of the e-IFU from the following website: https://www.e-ifu.com/search-document-metadata/radial%20head%20replacement%20system Forward this notice to all attending surgeons in your facility using this device. " Please complete, sign, and return the Business Reply Form within three (3) business days email to OneMD-Field-Actions@its.jnj.com (Please reference FA 2097468 in the subject line). Note: Product |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183618 | Revolution Radial Head Ignite Orthopedics, Inc., May 17, 2019 |