DePuy ATTUNE Knee Trial Instrument Recall Due to Balseal Disassociation Risk
DePuy Orthopaedics is recalling ATTUNE RP CR Articulation Surface trial 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 hazards without confirmed illness or injury.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 56,368 units of ATTUNE RP CR Articulation Surface trial instruments, sizes 3-8. These instruments are used during total knee replacement surgery to function as the 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, 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 product codes are 254500563, 254500564, 254500565, 254500566, 254500567, and 254500568.
The recall covers worldwide distribution, including the United States and numerous international locations. Healthcare providers and facilities should stop using these specific trial instruments and contact DePuy Orthopaedics for instructions on returning the affected units.
The recalled product
- Product
- ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 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 Surf
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 56,368
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 (11)
- Product Codes: 254500563
- 254500564
- 254500565
- 254500566
- 254500567
- and 254500568. GTIN: 10603295133032
- 10603295133049
- 10603295133056
- 10603295133063
- 10603295133070
- and 10603295133087.
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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