FDA Device recall Z-1072-2022
Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement
- FDA Device
- Class II
- ongoing
- Published 2022-05-18
On 2022-05-18 the FDA classified a Class II recall of Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement by Synthes Usa Products, citing dePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1072-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-04-07 |
| Published | 2022-05-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
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.
Identifiers
| code_info | All serial numbers. Material GTIN Product 03.405.000S 10886982300829 Radial Head Replace…All serial numbers. Material GTIN Product 03.405.000S 10886982300829 Radial Head Replacement Instr Kit; 09.405.250S 10886982300614 Rad Head w/Head 22 shaft 5.5 HH10 +0; 09.405.253S 10886982300621 Rad Head w/Head 22 shaft 5.5 HH10 +3; 09.405.256S 10886982300638 Rad Head w/Head 22 shaft 5.5 HH10 +6; 09.405.260S 10886982300645 Rad Head w/Head 22 shaft 6.5 HH10 +0; 09.405.263S 10886982300652 Rad Head w/Head 22 shaft 6.5 HH10 +3; 09.405.266S 10886982300669 Rad Head w/Head 22 shaft 6.5 HH10 +6; 09.405.270S 10886982300676 Rad Head w/Head 22 shaft 7.5 HH10 +0; 09.405.273S 10886982300683 Rad Head w/Head 22 shaft 7.5 HH10 +3; 09.405.276S 10886982300690 Rad Head w/Head 22 shaft 7.5 HH10 +6; 09.405.280S 10886982300706 Rad Head w/Head 22 shaft 8.5 HH10 +0; 09.405.283S 10886982300713 Rad Head w/Head 22 shaft 8.5 HH10 +3; 09.405.286S 10886982300720 Rad Head w/Head 22 shaft 8.5 HH10 +6; 09.405.560S 10886982300737 Rad Head w/Head 25 shaft 6.5 HH11 +0; 09.405.563S 10886982 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1072-2022%22
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