The Recall Desk
ModerateFDA (Devices)·Z-2260-2024·Announced 2024-07-10

Stryker Curved Cement Delivery Needles Recalled: Expired Products Distributed

Stryker recalled its Curved Cement Delivery Needle (Lot 6659783) due to expired product distribution. Three units were distributed to customers in Arkansas, California, Colorado, Florida, and Michigan.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This FDA Class II recall involves no reported illnesses or injuries. Expired product distribution constitutes a voluntary precautionary recall due to regulatory non-compliance, which per the rubric warrants a Moderate score.

Plain-English summary

Stryker Corporation recalled Curved, Super Elastic Cement Delivery Needles (Catalog Number 1025-011-500, Lot Number 6659783). This device is designed to pass through a cannula in a straight configuration and enter the vertebral body in a curved configuration, enabling physicians to inject bone cement into multiple areas through a single access point.

Three units of this device were distributed to customers in an expired condition. The recall affects customers in Arkansas, California, Colorado, Florida, and Michigan.

Facilities and healthcare providers who received this device should discontinue use and contact Stryker Corporation regarding return or replacement of the expired units.

The recalled product

Product
Curved, super elastic cement delivery needle that passes through the cannula in a straight configuration and enters the vertebral body in a curved configuration. This provides physicians with the ability to inject bone cement into multiple different areas through a single point o
Manufacturer
Stryker Corporation
Hazard
  • expiration
  • device-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 (1)

  • GTIN: 07613327374629 Lot Number: 6659783

Distribution

Distributed nationwide across the United States.