Symmetry Medical Recalls Collins Radioparent Sternal Blades Due to Breakage Risk
Symmetry Medical is recalling Collins Radioparent Sternal Blades because they may break during use. The recall covers 524 boxes distributed worldwide.
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 risk of breaking during use, which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Symmetry Medical/SSI is recalling the Codman(R) Collins Radioparent Sternal Blade Nylon, REF 50-8081. The recall is being conducted because there is a possibility that the blades may break during use.
The recall involves 524 boxes of 10 units. The product was distributed worldwide, including in the United States (California, Mississippi, Florida, Pennsylvania, Tennessee, Colorado, Illinois, Texas, Ohio, Michigan, Massachusetts) and internationally to Belgium, Canada, Germany, and the United Kingdom. Affected lot codes include 244576, 244582, 244584, 268916, 268920, 276513, 276514, 296136, 296139, 296141, 296153, 296155, 296156, 296157, and 296160.
The source text does not specify specific instructions for consumers or healthcare providers regarding the disposal or return of the recalled devices.
The recalled product
- Product
- Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4" (121 mm) long, 3" (76 mm) wide, 1 1/2" (38 mm) deep, REF 50-8081 sternum retractor
- Manufacturer
- Symmetry Medical/SSI
- Hazard
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 (15)
- 244576
- 244582
- 244584
- 268916
- 268920
- 276513
- 276514
- 296136
- 296139
- 296141
- 296153
- 296155
- 296156
- 296157
- 296160
Distribution
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