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.
Check against the official notice below — it lists the full affected range.
Synthes (USA) Products LLC is recalling the DePuy Synthes Radial Head Replacement System, which is a surgical implant used to replace the radial head bone in the elbow. The implant comes in different sizes (19mm, 22mm, and 25mm diameters) with varying stem lengths. The recall affects all serial numbers of this product that were distributed nationwide in the United States.
The reason for the recall is that contraindications have been added to the product's electronic instructions for use. Specifically, the instructions now identify absolute contraindications—meaning situations where the implant should not be used—including infection, sepsis, and osteomyelitis. The source record does not specify a remedy for consumers who already have this implant.
Written by software from the official notice below. Not reviewed by a lawyer.
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
Reason for recall: DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis. Distribution: US Nationwide distribution. Quantity: N/A Lot/code info: 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 10886982300744 Rad Head w/Head 25 shaft 6.5 HH11 +3; 09.405.566S 10886982300751 Rad Head w/Head 25 shaft 6.5 HH11 +6; 09.405.570S 10886982300768 Rad Head w/Head 25 shaft 7.5 HH11 +0; 09.405.573S 10886982300775 Rad Head w/Head 25 shaft 7.5 HH11 +3; 09.405.576S 10886982300782 Rad Head w/Head 25 shaft 7.5 HH11 +6; 09.405.580S 10886982300799 Rad Head w/Head 25 shaft 8.5 HH11 +0; 09.405.583S 10886982300805 Rad Head w/Head 25 shaft 8.5 HH11 +3; 09.405.586S 10886982300812 Rad Head w/Head 25 shaft 8.5 HH11 +6; 09.405.950S 10886982300522 Rad
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.