Reported Mar 7, 2018 · Terminated
Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows
Zimmer Biomet, 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 Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows
26 of 26 products
| Model / number | Product as published |
|---|---|
00894301906 | VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK ( ) |
00784302106 | VERSYS 6 INCH BEADED FC 21X160MM STD BODY STD NECK ( ) |
00784302206 | VERSYS 6 INCH BEADED FC 22X160MM STD BODY STD NECK ( ) |
00784301936 | VERSYS 6 INCH BEADED FC STEM 19X160MM LM ( ) |
00784302036 | VERSYS 6 INCH BEADED FC STEM 20X160MM LM ( ) |
00784302136 | VERSYS 6 INCH BEADED FC STEM 21X160MM LM ( ) |
00784302236 | VERSYS 6 INCH BEADED FC STEM 22X160MM LM ( ) |
00784301406 | VERSYS 6 INCH BEADED FC 14X160MM STD BODY STD NECK ( ) |
00784301506 | VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK ( ) |
00784301606 | VERSYS 6 INCH BEADED FC 16X160MM STD BODY STD NECK ( ) |
00784301706 | VERSYS 6 INCH BEADED FC 17X160MM STD BODY STD NECK ( ) |
00784301806 | VERSYS 6 INCH BEADED FC 18X160MM STD BODY STD NECK ( ) |
00784301826 | VERSYS 6 INCH BEADED FC 18X160MM STD BODY EXT NECK ( ) |
00784301926 | VERSYS 6 INCH BEADED FC 19X160MM STD BODY EXT NECK ( ) |
00784302006 | VERSYS 6 INCH BEADED FC 20X160MM STD BODY STD NECK ( ) |
00784302026 | VERSYS 6 INCH BEADED FC 20X160MM STD BODY EXT NECK ( ) |
00784302126 | VERSYS 6 INCH BEADED FC 21X160MM STD BODY EXT NECK ( ) |
00784302226 | VERSYS 6 INCH BEADED FC 22X160MM STD BODY EXT NECK ( ) |
00784301746 | VERSYS 6 INCH BEADED FC 17X160MM LM BODY XEXT NECK ( ) |
00784301756 | VERSYS 6 INCH BEADED FC 17X160MM LM BODY EXT NECK ( |
- Amount recalled
- 38,069 units total
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
The products being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
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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