DePuy ATTUNE Knee Trial Instruments Recalled for 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.
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 no injuries or illnesses have been reported in the source text.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 13,964 units of ATTUNE CONV RP CR ARTICULATION SURFACE Instruments in sizes 1, 2, 9, and 10. These instruments are intended to function as the Insert Trial during a total knee replacement. 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 from the post.
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 affected products were distributed worldwide, including in the United States and various international markets.
Healthcare providers should stop using the affected instruments and contact DePuy Orthopaedics for further instructions. Consumers who have had surgery using these instruments should contact their healthcare provider if they have concerns.
The recalled product
- Product
- ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 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
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 13,964
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 (7)
- Product Codes:254500981
- 254500982
- 254501989
- and 254501990. GTIN: 10603295135586
- 10603295135593
- 10603295423492
- and 10603295423959.
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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