The Recall Desk
HighFDA (Devices)·Z-1072-2022·Announced 2022-05-18

Radial Head Replacement System implant: contraindications added to safety instructions

Synthes has updated safety instructions for its Radial Head Replacement System implant with absolute contraindications for use in patients with infection, sepsis, or osteomyelitis. The FDA has classified this as a Class II recall.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall with no reported illnesses or adverse events. The contraindications address serious patient conditions (infection, sepsis, osteomyelitis), but the hazard is theoretical and preventive, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Synthes (USA) Products LLC has updated the electronic instructions for use (e-IFU) for its Radial Head Replacement System implant. The device is a one-piece, stemmed radial head replacement used in orthopedic surgery, available in diameters of 19, 22, and 25 millimeters with stems ranging from 5.5 to 8.5 millimeters in diameter.

The manufacturer has added absolute contraindications to the instructions, specifying that the implant should not be used in patients with active infection, sepsis, or osteomyelitis. This update is classified as a Class II recall by the FDA.

The implant has been distributed nationwide in the United States. Patients who have received this implant and their healthcare providers should review the updated instructions. If you have questions about whether these contraindications apply to your implant or treatment, consult your healthcare provider or contact Synthes.

The recalled product

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.
Manufacturer
Synthes (USA) Products LLC
Category
Medical Device — Orthopedic Implant
Hazard
  • contraindicated-use

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

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