Reported Sep 10, 2014 · Terminated
PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD…
Zimmer, 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: Zimmer, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
16 of 16 products
| # | Product as published |
|---|---|
| 1 | PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top |
| 2 | Size 6-9 CD Top |
| 3 | Size 3-5 EF Top |
| 4 | Size 6-9 EF Top |
| 5 | Size 10-11 EF Top |
| 6 | Size 6-9 GH Top |
| 7 | Size 10-12 GH Top |
| 8 | Size 10-12 J Top |
| 9 | and RIGHT Size 3-5 CD Top |
| 10 | Right Size 6-9 CD Top |
| 11 | Right Size 3-5 EF Top |
| 12 | Right Size 6-9 EF Top |
| 13 | Right Size 10-11 EF Top |
| 14 | Right Size 6-9 GH Top |
| 15 | Right Size 10-12 GH Top |
| 16 | and Right Size 10-12 J Top. |
- Lot codes and dates
- Part Numbers
425174004104251740051042517400610425174007104251740081042517400910425174010104251740111042527400410425274005104252740061042527400710425274008104252740091042527401010and 42527401110
- Lot numbers
299 of 299 codes
620435566211004562121489621255896214723562165546621683836217724762311021623147226238642162442838625254916255858562605208626272926268343262696865627173436202234462041351620735666210437262117744621214886214917562187324621873256224735162311022623147236236496162391117624364686247490362538403625643116261108962669905626908956272022562742767627477076202094662028233620735706211004762130976621873276218732962189325622908226230540762314724623864246242025862469459625316626255135662565041
- Part Numbers
- Amount recalled
- 77,737 total units
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was recalled
Reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The Persona primary knee surgical technique has been updated. This field action correction is to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.
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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