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.
FDA Recall Z-1072-2022 · Posted None
Recalling FirmSynthes (USA) Products LLC
Recall StatusOpen, Classified
Product CodeKWI
Date Initiated2022-04-07
Reason for Recall
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
Firm 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 [email protected] (Please reference FA 2097468 in the subject line).
Note: Product is NOT being removed from the field and does not need to be returned.
Root Cause
Labeling Change Control
Distribution Pattern
US Nationwide distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.