Stryker Infinity Resection Adjustment Block Recall: Missing Locking Screw
Stryker recalled specific lots of Infinity Resection Adjustment Blocks due to a missing internal screw that locks the medial/lateral adjustment mechanism. The defect affects 47 units used in ankle arthroplasty procedures.
What this means for you
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 recall for a surgical instrument with a structural defect (missing internal locking screw). Although no injuries or hospitalizations have been reported, the defect poses a risk of harm by potentially preventing proper locking of a safety-critical adjustment mechanism used during ankle arthroplasty surgery.
Plain-English summary
Wright Medical Technology, Inc. (doing business as Stryker) recalled specific lots of the Infinity Resection Adjustment Block (REF 33600030), a surgical instrument used in ankle arthroplasty procedures. The affected lot numbers are 2656950, 2762126, and 2796094. A total of 47 units were distributed.
The recall was initiated because the instruments in these lots are missing an internal screw in the finished assembly. This screw is critical for locking the medial/lateral adjustment on the Infinity Resection Adjustment Guide. Without this screw, the adjustment mechanism may not lock properly during use.
The recalled devices were distributed to healthcare facilities in Texas and Nebraska, and internationally to Australia, Belgium, Brazil, Canada, China, Colombia, France, Germany, Italy, Spain, Sweden, Switzerland, and the United Kingdom.
Healthcare providers and facilities that received devices with the affected lot numbers should verify the lot number before use. Contact Wright Medical Technology, Inc. for instructions on replacement or return of the affected instruments.
The recalled product
- Product
- stryker Infinity Resection Adjustment Block, REF 33600030, ankle arthroplasty
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- missing-component
- adjustment-lock-failure
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 (4)
- UDI/DI 00889797004008
- Lot Numbers: 2656950
- 2762126
- 2796094
Distribution
Distributed in 2 states:
- NE
- TX
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