Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM
Reported: February 7, 2018 Initiated: August 7, 2017 #Z-0442-2018
Product Description
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM
Reason for Recall
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 638 units
- Distribution
- US nationwide distribution. Also Portugal and the Netherlands.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 300MM. Recalled by Zimmer Biomet, Inc.. Units affected: 638 units.
Why was this product recalled? ▼
During the rework process for the April 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. This could prevent the product assembly with the mating screw and targeting jig.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 7, 2018. Severity: Moderate. Recall number: Z-0442-2018.
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