Synthes LCP Drill Sleeve Recall Due to Connection and Alignment Issues
Synthes, Inc. is recalling LCP Drill Sleeve 1.5 Drill Bits because they may fail to attach to plates, potentially causing surgical delays or off-center drilling.
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 involves a medical device defect that could lead to surgical complications such as screw or plate loosening, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Synthes, Inc. is recalling 567 units of the LCP Drill Sleeve 1.5 Drill Bit 1.1mm (Part Number 03.114.001). These devices are used in the LCP Modular Mini Fragment System for the fixation of small bones and small bone fragments. The affected lot numbers are FT00227, 9972971, H028400, H161606, and H288454.
The recall was initiated because the drill sleeve may have difficulty attaching to the plate. If the sleeve does not connect intraoperatively, it could cause a delay in the surgery. Additionally, if the pilot hole is drilled without the sleeve, the hole may be off-center, which could result in the loosening of the screw and/or plate.
The affected products were distributed to the United States, Canada, and Germany. Healthcare providers and facilities should stop using these specific devices and contact Synthes, Inc. for instructions on how to return or replace the affected units.
The recalled product
- Product
- LCP Drill Sleeve 1.5 Drill Bit 1.1mm Part Number 03.114.001 Used in LCP Modular Mini Fragment System, for fixation of small bones and small bone fragments
- Manufacturer
- Synthes, Inc.
- Affected units
- 567
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)
- Lot numbers FT00227 9972971 H028400 H161606 H288454
Distribution
Distribution scope not specified by the agency.
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