Stryker Infinity Alignment Frame Distal Sub-Assembly Recalled for Manufacturing Defect
Wright Medical Technology is recalling the Stryker Infinity Alignment Frame Distal Sub-Assembly due to manufacturing defects that prevent proper assembly. The pin sleeve holes were manufactured too narrow, preventing insertion of pin sleeves and proper device configuration.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device with a manufacturing defect that prevents proper assembly and function. It is a risk-of-harm product, as a medical device component that cannot be properly assembled poses potential risks in its intended use. No illnesses or injuries have been reported.
Plain-English summary
Wright Medical Technology, Inc. is recalling the Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile. The recall affects 106 devices with lot numbers 2656815 and 2762126.
The devices were manufactured with pin sleeve holes that are too narrow to allow pin sleeves to pass through, preventing proper pin placement and device assembly. This manufacturing defect makes the devices unsuitable for their intended use.
The affected devices were not distributed in the United States, including to government and military facilities. International distribution occurred to Australia, Belgium, Canada, Chile, China, Colombia, France, Germany, Italy, Mexico, Netherlands, Spain, Sweden, Switzerland, Taiwan, and the United Kingdom.
Affected users in these countries should contact Wright Medical Technology, Inc. for information regarding this recall.
The recalled product
- Product
- Stryker Infinity Alignment Frame Distal Sub-Assembly, Catalog #33600020, non-sterile.
- Manufacturer
- Wright Medical Technology, Inc.
- Affected units
- 106
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 (2)
- Lot numbers 2656815 and 2762126
- UDI-DI 00889797003926.
Distribution
Distribution scope not specified by the agency.
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