DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Separation 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 where a foreign object could be left in a patient, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for theoretical risk.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling ATTUNE Knee Tibial Articulation Surface Instruments (sizes 3-10) due to a potential defect in the Balseal component. The Balseal is a small wire spring coil located on the post feature of the instrument, which is used to function as an Insert Trial during total knee replacement surgery.
The recall is issued because the Balseal has the potential to become damaged and disassociate (come off) from the post. If this separation occurs, the Balseal has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
The affected units were distributed worldwide, including the United States and numerous international locations. Healthcare providers and facilities should stop using the affected instruments and contact DePuy Orthopaedics for instructions on returning or replacing the devices.
The recalled product
- Product
- ATTUNE CONV FB CR TB TRL SZ3 - 10 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 Surface to
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 14,756
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)
- Product Codes:254501963
- 254501964
- 254501965
- 254501966
- 254501967
- 254501968
- 254501969
- and 254501970. GTIN: 10603295423355
- 10603295423362
- 10603295423379
- 10603295423386
- 10603295423393
- 10603295423409
- 10603295423416
- and 10603295423423.
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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