Miltex Chisel Blade Handle Recall Due to Insecure Blade Fit
Integra York PA, Inc. is recalling Miltex Premium Grade Self-Lock Chisel Blade Handles because a wider slot may prevent the blade from securing firmly.
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: The recall involves a medical device with a functional defect that could lead to injury during surgery, but the source text does not report any specific injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Integra York PA, Inc. is recalling 678 units of Miltex Premium Grade Self-Lock Chisel Blade Handles, Catalogue No. 4-405, Lot # 97327. The recall involves a manual surgical instrument distributed worldwide, including the United States, Mexico, and Korea.
The recall was initiated because one lot of the handles features a wider slot that holds the chisel blade. This design defect may result in the inability to firmly secure the blade in the handle, posing a risk of the blade becoming dislodged during use.
Healthcare facilities and users should stop using the affected chisel blade handles immediately. Users should contact the recalling firm for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
- Manufacturer
- Integra York PA, Inc
- Hazard
- Affected units
- 678
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)
- Catalogue No. 4-405
- Lot # 97327
Distribution
Distributed nationwide across the United States.
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