Reported Mar 30, 2016 · Terminated
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog #…
Arthrex, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Arthrex, Inc. · 1370 Creekside Blvd · Naples, FL · 34108-1945
Is this the product you have?
- 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 implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).
- Lot codes and dates
- Size 2 Unique Device Identifier
00888867106703 Batch #'s: 927692915207982771979834982774120616412061651206167120616612273881227387125719512336201289648123362112896531289736128965413364301336431130572113063321352062133643313364361352058135206313761041376106and 1376107
- Size 3 Unique Device Identifier
00888867106710 Batch #'s: 78083895278912061691206170120616811913371191337127272812970481297044129704912727301272729130726212970601297057129736513072631336445130726713364511336448133645113072651336453134695813469621346982134699413469651336452137908513791041379110137911313791141346999and 1379084
- Size 4 Unique Device Identifier
00888867106727 Batch #'s: 894339913623874733876482876478119133812061721206173129707512970841315459129708612973661311545313154541315459131546213154641336466133646513364671336455133646813336469135652713565301356531135652913565741379205137920313792041379206137920013565761379196and 1379201
- Size 5 Unique Device Identifier
00888867106734 Batch #'s:78084097120212061761206177135658613225231380216138022313802241356588138022113802261555653and 1555654
- Size 6 Unique Device Identifier
00888867106741 Batch #'s:78084197036812061781206179132245913224601322524135778513802431380244138024513802461357786and 1380242
- Size 7 Unique Device Identifier
00888867106758 Batch #'s: 780842982767984546120618013372301206181133723413372371337240133724113372561358297135829913582981358300135830213807081380709and 1380710
- Size 8 Unique Device Identifier
00888867106765 Batch #'s: 91362497086595705611913421224471120800119134111913398764848764851228632125102112921541251022128169912921611293756129375813072941307295130853813372621337300133730313470121347013133732513470141380743134702513807471380748and 1380742
- Size 2 Unique Device Identifier
- Amount recalled
- 2,378 units.
Where it was sold
Why it was recalled
Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.
This product could cause temporary or reversible health problems — stop using it.
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