Biomet Recalls Oversized Security Blades for Carpal Tunnel Surgery
Biomet, Inc. is recalling 1,130 Security Blades for carpal tunnel surgery because they were manufactured oversized and may be difficult to advance through the mating clip.
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: The recall is classified as FDA Class II and involves a risk-of-harm product where the defect could impede a surgical procedure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Biomet, Inc. is recalling 1,130 units of the REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade (Single). These are sterile, single-use medical devices designed to release the transverse carpal ligament during carpal tunnel surgery. The recall is due to a manufacturing defect where the blades were produced oversized.
The oversized blades may not advance or may be difficult to advance through the mating Security Clip. The affected devices were distributed nationwide in the United States and internationally to Japan. The recall includes specific lot numbers identified in the agency's structured data.
Healthcare providers and patients should stop using these specific blades and contact Biomet, Inc. for further instructions or a replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- REF 200068 Security (TM) Enclosed Carpal Tunnel System Blade ( Single) ABS /Stainless Steel Sterile Device, Single Use Only. Designed to release the transverse carpal ligament.
- Manufacturer
- Biomet, Inc.
- Affected units
- 1,130
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 (14)
- 090600
- 143810
- 257060
- 289900
- 365910
- 460490
- 558300
- 626660
- 697320
- 767260
- 795090
- 857730
- 864640
- 979680
Distribution
Distributed nationwide across the United States.
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