Recall Z-1219-2015— Zimmer, Inc.

Name: FDA recall Z-1219-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-05

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2015-02-05, terminated 2015-09-23. It names one FDA 510(k) clearance: K101296. Product: Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.. Reason: PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-02-05
Terminated: 2015-09-23
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K101296 — ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONSZimmer, Inc.·cleared 2010-07-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.

Reason for recall

PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating.

Data sourced from openFDA. This site is unofficial and independent of the FDA.