Synthes Torque Limiting Handle Recalled Due to Premature Rusting
Synthes (USA) Products LLC is recalling 50 Torque Limiting Handles because high-carbon ball bearings may rust prematurely, causing functional degradation.
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 is classified as FDA Class II. The hazard involves functional degradation due to rusting in a device used for fracture fixation, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Synthes (USA) Products LLC is recalling 50 units of the Synthes Torque Limiting Handle, Part Number 03.231.013. This medical device is used in systems indicated for fracture fixation. The recall covers specific lot codes ranging from H344006-02 to H344006-49, as well as H369323-03 and H369323-04.
The recall was initiated because the adapter may demonstrate a degradation of function. The final products were assembled with ball bearings of high carbon content that are likely to rust prematurely. This rusting can compromise the device's performance during use.
The affected units were distributed nationwide in the United States to the states of AK, CA, FL, ID, IN, KS, KY, LA, MD, MI, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, UT, WI, and WV. Healthcare facilities and users should stop using the affected devices and contact the manufacturer for instructions on replacement or return.
The recalled product
- Product
- Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 50
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 (20)
- H344006-02
- H344006-03
- H344006-04
- H344006-05
- H344006-06
- H344006-07
- H344006-08
- H344006-09
- H344006-10
- H344006-11
- H344006-12
- H344006-13
- H344006-14
- H344006-15
- H344006-16
- H344006-17
- H344006-18
- H344006-19
- H344006-20
- H344006-21
Distribution
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