The Recall Desk
HighFDA (Devices)·Z-1694-2021·Announced 2021-06-09

Hip implant cup liner recalled for mislabeling and wrong product in package

Signature Orthopedics is recalling Logical cup liners (hip implants) due to mislabeling with incorrect products in the package. Affected devices may not be suitable for implantation.

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 recall of an orthopedic implant with mislabeling and incorrect product packaging. Although no illnesses or injuries have been reported, the use of an incorrect hip implant could result in serious harm to patients, meeting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Signature Orthopedics Pty Limited is recalling Logical cup liners, orthopedic implants designed to replace hip joints when bone stock is sufficient to support the device.

The recall was initiated because product packaging is mislabeled, with incorrect products contained inside the package. This defect could result in the wrong implant being used during surgery.

The recall affects 3 units distributed in North Carolina, identified as LOT# 71541-1.

Healthcare providers and patients who have received devices from this lot should contact Signature Orthopedics immediately. If an affected device has been implanted, the patient should consult their surgeon.

The recalled product

Product
Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant.
Manufacturer
Signature Orthopedics Pty Limited
Hazard
  • mislabeling
  • wrong-product

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 (1)

  • LOT# 71541-1

Distribution

Distributed nationwide across the United States.