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 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.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling 61,556 units of ATTUNE RP PS Articulation Surface Instruments, sizes 3-8. These instruments are used as trials during total knee replacement surgeries. 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 detach from the post.
If the Balseal separates from the post, there is a risk that it could enter the surgical site and be left inside the patient if the surgeon is unaware of the detachment. The affected units 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 instructions on how to return or replace the units. Patients who have had knee replacement surgery using these specific trial instruments should contact their surgeon to discuss their medical history and any potential concerns.
The recalled product
- Product
- ATTUNE RP PS 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 Su
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 61,556
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: 254500543
- 254500544
- 254500545
- 254500546
- 254500547
- and 254500548. GTIN: 10603295132837
- 10603295132844
- 10603295132851
- 10603295132868
- 10603295132875
- and 10603295132882.
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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