Stryker Infinity Alignment Frame Distal Sub-Assembly recall
Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
Why was Stryker Infinity Alignment Frame Distal Sub-Assembly 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers 2656815 and 2762126, UDI-DI 00889797003926.
- Product
- Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 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.
- Recall date
- July 12, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)