PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 10, 2018 Initiated: June 29, 2017 #Z-0312-2018

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.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
15 units
Distribution
Distributed domestically to MI, MN, ND.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Zimmer Biomet, Inc.. Units affected: 15 units.
Why was this product recalled?
Device was distributed with the etching missing from the product.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 10, 2018. Severity: Moderate. Recall number: Z-0312-2018.