Orthopedic Surgical Blade Recall Due to Incorrect Configuration
Beaver Arthro-Lok surgical blades may have been configured to curve right instead of left. If used during surgery, the incorrect curve could cause unintended tissue damage.
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 device recall involving a configuration defect that could cause unintended tissue damage during orthopedic surgery. No injuries or hospitalizations have been reported, but the risk-of-harm nature of the defect in a surgical instrument warrants a High severity rating.
Plain-English summary
Beaver Visitec International is recalling Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade surgical instruments due to incorrect blade configuration. The distributed blades curve to the right instead of to the left.
These orthopedic blades are used in various surgical procedures including foot, ankle, hand, knee, hip, and spine surgery. If the incorrectly curved blades are used during surgery, they may cause unintended tissue damage. If the configuration error is noticed prior to use, it may cause a delay in the scheduled procedure.
Approximately 150 units were distributed in the United States (Florida, Georgia, Indiana, Louisiana, Massachusetts, Maine, and Virginia) and 1,116 units were distributed internationally (France, Japan, Netherlands, Switzerland, and the United Kingdom). Affected lot numbers are 6034831 and 6039837.
Healthcare providers should inspect Beaver Arthro-Lok blades before use to verify correct left-curve configuration. Any questions or concerns should be directed to Beaver Visitec International or the FDA.
The recalled product
- Product
- Beaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic blade, which may be used in various types of orthopedic surgery (i.e. foot, ankle, hand, knee, hip or spine surgery). Catalog#: 376780
- Manufacturer
- Beaver Visitec International, Inc.
- Hazard
- tissue-damage
- configuration-error
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)
- UDI# 00886158001249 LOT#'s: 6034831
- 6039837
Distribution
Distributed in 7 states:
- FL
- GA
- IN
- LA
- MA
- ME
- VA
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