Recall Z-1072-2022— Synthes (USA) Products LLC
Class II · Ongoing
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2022-04-07. It names one FDA 510(k) clearance: K183618. Product: 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.. Reason: DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis..
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-04-07
- Firm location
- West Chester, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
Data sourced from openFDA. This site is unofficial and independent of the FDA.