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 (foreign object retention in a patient) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling the ATTUNE CONV RP PS ARTICULATION SURFACE (sizes 1-9). These instruments are used during total knee replacement surgeries to function as the Insert Trial. The recall involves 11,360 units distributed worldwide, including the United States and numerous international locations.
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, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any specific illnesses or injuries. The recall is classified as Class II by the FDA.
The recalled product
- Product
- ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 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
- 11,360
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 (17)
- Product Codes:254500991
- 254500992
- 254500993
- 254500994
- 254500995
- 254500996
- 254500997
- 254500998
- and 254500999. GTIN: 10603295135685
- 10603295135692
- 10603295135708
- 10603295135715
- 10603295135722
- 10603295135739
- 10603295135746
- 10603295135753
- and 10603295135760.
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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