🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: April 7, 2022 Synthes (USA) Products Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    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 Head w/Head 19 shaft 5.5 HH9 +0; 09.405.953S 10886982300539 Rad Head w/Head 19 shaft 5.5 HH9 +3; 09.405.956S 10886982300546 Rad Head w/Head 19 shaft 5.5 HH9 +6; 09.405.960S 10886982300553 Rad Head w/Head 19 shaft 6.5 HH9 +0; 09.405.963S 10886982300560 Rad Head w/Head 19 shaft 6.5 HH9 +3; 09.405.966S 10886982300577 Rad Head w/Head 19 shaft 6.5 HH9 +6; 09.405.970S 10886982300584 Rad Head w/Head 19 shaft 7.5 HH9 +0; 09.405.973S 10886982300591 Rad Head w/Head 19 shaft 7.5 HH9 +3; 09.405.976S 10886982300607 Rad Head w/Head 19 shaft 7.5 HH9 +6.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Synthes (USA) Products LLC
Reason for Recall:
DePuy Synthes Radial Head Replacement System Contraindications added to Electronic Instructions for Use (e-IFU): Absolute contraindications include: Infection, sepsis, osteomyelitis.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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.

Product Codes/Lot Numbers:

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 Head w/Head 19 shaft 5.5 HH9 +0; 09.405.953S 10886982300539 Rad Head w/Head 19 shaft 5.5 HH9 +3; 09.405.956S 10886982300546 Rad Head w/Head 19 shaft 5.5 HH9 +6; 09.405.960S 10886982300553 Rad Head w/Head 19 shaft 6.5 HH9 +0; 09.405.963S 10886982300560 Rad Head w/Head 19 shaft 6.5 HH9 +3; 09.405.966S 10886982300577 Rad Head w/Head 19 shaft 6.5 HH9 +6; 09.405.970S 10886982300584 Rad Head w/Head 19 shaft 7.5 HH9 +0; 09.405.973S 10886982300591 Rad Head w/Head 19 shaft 7.5 HH9 +3; 09.405.976S 10886982300607 Rad Head w/Head 19 shaft 7.5 HH9 +6.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1072-2022

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