Reported Apr 10, 2024 · Ongoing
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number…
Exactech, 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: Exactech, Inc. · 2320 Nw 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
- Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature
- Sizesa) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty
- Lot codes and dates
a) Item Number 314-01-12UDI/DI 10885862084439
- Serial Numbers
308 of 308 codes
074417007566030744142074416907441780744141074415207441820756566075659207566110744134074413507565910744177075656707565820756606075659607441790744159074414511175151117547111753711175171117520111754811175101117543111752911175021117535111749911175081117546111750311175281117536111750611175451117521111750511175121117516127240013610601361065127239812724011272392127240312724080756602111754013922341350740135073613610701361071
- Serial Numbers
967 of 967 codes
074261507423970742650074241207424850746496074249807426080742432074242307425130742616074247807424880742489074249507424800742494074241107424070742398074239907426410742516074251707684350742393074240507425110742637074250507426270742438074261907426060742609074239507426210742618074247607425200768458074242607424280768443074250807424960742429074242007424390742612074241807684620742493074251507424080742640074240907424160742396
- Serial Numbers
737 of 737 codes
074266607426600742675074266207426960742663074268607430430742659074299207426780742682074299907430060743041074265707426580742661074269707426680743005074300307430120903127074303907429930743018074268807429900742672074302007430350742680074301107430260742991090317009031640903150074302309031350743037074300809031590742654074266907429970742687074269807430220743038074298907430330903167090311709031180903157090314509031690903147
- Amount recalled
- 2008 units
This recall covers 24 products
The agency filed one notice per product. You are reading one of them; the other 23 are below.
11 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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