Recall Z-0312-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-0312-2018
Creator: U.S. Food and Drug Administration
Published: 2017-06-29

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-06-29, terminated 2018-03-07. It names one FDA 510(k) clearance: K093235. Product: PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended for uncemented use only.. Reason: Device was distributed with the etching missing from the product..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-29
Terminated: 2018-03-07
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K093235 — RINGLOC + HYBRID ACETABULAR SYSTEMBiomet, Inc.·cleared 2010-04-30

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

PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended for uncemented use only.

Reason for recall

Device was distributed with the etching missing from the product.

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