3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.
Reported: October 31, 2018 Initiated: September 12, 2018 #Z-0238-2019
Product Description
3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.
Reason for Recall
The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.
Details
- Recalling Firm
- Synthes (USA) Products LLC
- Units Affected
- 20
- Distribution
- US Distribution to the following states: AR, AZ, FL, IL, NM, OH, and TX.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.. Recalled by Synthes (USA) Products LLC. Units affected: 20.
Why was this product recalled? ▼
The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 31, 2018. Severity: Moderate. Recall number: Z-0238-2019.
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