Terumo Sternal Retractor Locking Mechanism Recall for Fracture Risk
Terumo is recalling 12 sternal retractor devices because the stainless steel locking plates may fracture. The devices were distributed in eight US states.
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 risk-of-harm product (potential fracture of a locking mechanism) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 12 units of a sternal retractor device. The product consists of a distal connection mechanism, an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.
The recall is being issued because there is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture. The affected devices were distributed in the US states of New Hampshire, Wisconsin, New Jersey, Pennsylvania, Nevada, Maryland, and Tennessee. The specific units are identified by Catalog Number T401163 and Serial Numbers T00393, T00394, T00395, T00399, T00403, T00405, T00406, T00407, T00408, T00410, T00411, and T00412.
Healthcare facilities and consumers should stop using the affected devices and contact Terumo Cardiovascular Systems Corporation for further instructions on how to return or replace the units.
The recalled product
- Product
- Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 12
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 (12)
- GTIN Code: (01)00699753450950 Catalog Number: T401163 Serial Numbers: T00393
- T00394
- T00395
- T00399
- T00403
- T00405
- T00406
- T00407
- T00408
- T00410
- T00411
- T00412.
Distribution
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