The Recall Desk
HighFDA (Devices)·Z-1667-2022·Announced 2022-09-07

Hip Implant Stem Recalled for Failed Fatigue Testing

Corin Ltd is recalling a hip implant stem component (Model 588.3800) after some units failed fatigue testing. The affected devices were distributed to New Jersey only.

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 an FDA Class II medical device recall where some units failed fatigue testing. Although no injuries or illnesses have been reported, a hip implant with potential structural failure presents a risk of harm to patients. This meets the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Corin Ltd is recalling the TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper with 188.550 Centraliser (Model 588.3800, Lot 494754), an orthopedic hip implant component used in hip replacement surgery.

Some of the recalled devices did not pass fatigue testing.

The recalled devices were distributed to New Jersey only. Patients who received this implant should contact their healthcare provider to verify if they are affected.

The recalled product

Product
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
Manufacturer
Corin Ltd
Category
Medical Device — Orthopedic Implant
Hazard
  • device-failure
  • fatigue-failure

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 (3)

  • Model #588.3800
  • Lot #494754
  • UDI 05055343871065

Distribution

Distributed in 1 state:

  • NJ

Related recalls

Same category