DePuy ATTUNE Knee Trial Instrument Recall Due to Balseal Detachment Risk
DePuy Orthopaedics is recalling ATTUNE Knee Tibial Articulation Surface Instruments because a small wire spring coil (Balseal) may detach and be left in the patient during surgery.
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 risk-of-harm product (foreign object retention in a patient) where injury has not yet been reported, fitting the High severity criteria for theoretical or unreported harm risks.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 3,474 units of the ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 instruments. These instruments are used during total knee replacement surgeries to function as an Insert Trial. The recall is due to a potential defect where the Balseal, a small wire spring coil located on the post feature of the instrument, may become damaged and disassociate (come off).
If the Balseal separates from the post, there is a potential for it to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation. The affected product codes are 254500961 and 254500962, with GTINs 10603295135388 and 10603295135395.
The recall covers worldwide distribution, including the United States and numerous international locations such as Canada, Australia, and various countries in Europe, Asia, and South America. Healthcare providers and facilities that have used or possess these instruments should contact DePuy Orthopaedics for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation S
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 3,474
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)
- Product Codes:254500961 and 254500962. GTIN: 10603295135388 and 10603295135395.
Distribution
Part of a larger recall action
This product is one of 10 recalled by DePuy Orthopaedics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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