Biomet Recalls Superior Approach Resection Guide Assembly Due to Slot Offset
Biomet is recalling 17 units of the Superior Approach Resection Guide Assembly because a manufacturing defect may prevent the guide from securing properly to bone during surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the defect involves a structural failure of a surgical guide that could lead to improper placement during a procedure, meeting the criteria for a Severe rating.
Plain-English summary
Biomet, Inc. is recalling 17 units of the Superior Approach Resection Guide Assembly. This medical device is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain. The affected units are identified by catalog number 010001814 and lot numbers 318520 and 644720.
The recall was initiated after an investigation identified that the slot on the resection guide is offset in the wrong direction. This defect may prevent the Steinman pin, which is intended to hold the guide into place, from coming into contact with the bone. The agency has classified this recall as Class II.
The affected products were distributed worldwide, including nationwide in the United States (specifically Utah, Texas, Alabama, Kentucky, and Wisconsin) and in Australia, The Netherlands, Korea, and Canada. Healthcare providers should stop using the affected devices and contact Biomet for further instructions.
The recalled product
- Product
- Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
- Manufacturer
- Biomet, Inc.
- Affected units
- 17
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 (1)
- Catalog number: 010001814 and lot numbers: 318520 and 644720.
Distribution
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