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.
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 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 imp
- Manufacturer
- Arthrex, Inc.
- 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
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