Agency classClass IIOur severity:High FDA (Devices)·Z-1195-2016·Announced 2016-03-30

Arthrex Recalls IBalance TKA Tibial Trays Due to Surface Texture Defect

Arthrex, Inc. is recalling 2,378 IBalance TKA Tibial Trays because the outer metal surface is smooth instead of textured. The devices were distributed nationwide.

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 medical device with a manufacturing defect (smooth vs. textured surface) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Arthrex, Inc. is recalling 2,378 units of the IBalance TKA Tibial Tray, sizes 2 through 8. The recall involves specific catalog numbers and batch numbers for each size, which are listed in the official FDA record. These medical devices are intended for implantation with bone cement, with the exception of porous coated femoral components which can be used cemented or uncemented.

The recall was initiated because the devices were reported to have a smooth texture on the outer surface of the metal. This differs from previous versions of the device, which had a textured outer surface. The source text does not report any specific injuries, illnesses, or deaths associated with this defect.

The affected devices were distributed nationwide to the following states and districts: AR, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, WA, WI, and the District of Columbia. Healthcare providers and patients should consult the FDA recall notice for specific batch and lot numbers to identify affected units.

The recalled product

Product: Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for…
Manufacturer: Arthrex, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: manufacturing-defect
surface-texture
Affected units: 2,378

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 (20)

Size 2 Unique Device Identifier: 00888867106703 Batch #'s: 927692
915207
982771
979834
982774
1206164
1206165
1206167
1206166
1227388
1227387
1257195
1233620
1289648
1233621
1289653
1289736
1289654
1336430
1336431

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically:

Same manufacturer · Arthrex, Inc.

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