DePuy ATTUNE Knee Trial Instrument Recall 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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 5,185 units of the ATTUNE CONV RP PS TB TRL SZ10 Tibial Articulation Surface Instruments. These instruments are used during total knee replacement surgery to function as an 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 products were distributed worldwide, including in the United States and numerous international locations.
Healthcare providers and facilities should stop using the affected instruments and contact DePuy Orthopaedics for instructions on how to return or replace the devices. Consumers who have had knee replacement surgery using these specific instruments should contact their healthcare provider to discuss the recall and any potential concerns.
The recalled product
- Product
- ATTUNE CONV RP PS TB TRL SZ10 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
- 5,185
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 (1)
- Product Codes:254501000 and GTIN: 10603295135777
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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