Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Reported: July 12, 2023 Initiated: June 13, 2023 #Z-2105-2023
Product Description
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Reason for Recall
The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.
Details
- Recalling Firm
- Wright Medical Technology, Inc.
- Units Affected
- 106 devices
- Distribution
- There was no U.S. distribution, including government and military. Foreign distribution was made to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.. Recalled by Wright Medical Technology, Inc.. Units affected: 106 devices.
Why was this product recalled? ▼
The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 12, 2023. Severity: Moderate. Recall number: Z-2105-2023.
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