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510(k) K973714 · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

VERSYS HIP SYSTEM BEADED HIP PROSTHESIS

Applicant	Zimmer, Inc., Warsaw IN, US
Decision	Substantially Equivalent, Dec 24, 1997
Received	Sep 29, 1997
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K973714

Date	Firm and product	Code	Linked 510(k)
Nov 29, 2017	Zimmer Biomet, Inc. VERSYS 6 INCH BEADED FC 12X160MM LM BODY EXT NECK VERSYS BEADED FULLCOAT REVISION HIP PROSTHESIS Terminated	LPH	None listed
Nov 29, 2017	Zimmer Biomet, Inc. VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Terminated	LPH	None listed
Nov 29, 2017	Zimmer Biomet, Inc. VERSYS 6 INCH BEADED FC 14X160MM STD BODY EXT & STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Terminated	LPH	None listed
Nov 29, 2017	Zimmer Biomet, Inc. VERSYS 6 INCH BEADED FC 15X160MM STD BODY STD NECK Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Terminated	LPH	None listed
Nov 29, 2017	Zimmer Biomet, Inc. VERSYS 6 INCH BEADED FC STEM 12X160MM LM 13X160MM LM 15X160MM LM 17X160MM LM Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Terminated	LPH	None listed
Aug 1, 2017	Zimmer Biomet, Inc. Versys 6 inch Beaded Full Coat Plus Hip Prosthesis. Labeled as follows: a. VERSYS 6 INCH BEADED FC 19X160MM STD BODY STD NECK (Item No. 00894301906); b. VERSYS 6 INCH BEADED FC 21X160MM STD BODY Terminated	LPH	None listed
Feb 22, 2016	Zimmer Biomet, Inc. VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, os Terminated	LPH	None listed
Jun 20, 2014	Zimmer, Inc. VerSys Hip System, Beaded Fullcoat Stems, Zimmer, Inc., Warsaw, IN 46581 Terminated	LPH	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.