DePuy ATTUNE Knee Trial Instruments Recalled for Balseal Detachment Risk
DePuy Orthopaedics is recalling ATTUNE FB PS 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of a foreign object (Balseal) being left in a patient during surgery, which constitutes a significant injury risk.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling the ATTUNE FB PS Articulation Surface instruments, sizes 3-8. These instruments are used during total knee replacement surgeries to function as the Insert Trial. The recall involves 34,676 units that were distributed worldwide, including the United States, Canada, 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 agency classifies this as a Class II recall. Healthcare providers should stop using the affected instruments and contact DePuy Orthopaedics for instructions on how to return or dispose of the devices.
The recalled product
- Product
- ATTUNE FB PS ARTICULATION SURFACE SIZES 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…
- Manufacturer
- DePuy Orthopaedics, Inc.
- Affected units
- 34,676
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: 254500503
- 254500504
- 254500505
- 254500506
- 254500507
- and 254500508. GTIN: 10603295132431
- 10603295132448
- 10603295132455
- 10603295132462
- 10603295132479
- and 10603295132486.
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.
See all 10 products in this recall →Related recalls
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