FDA recall Z-0312-2018

Zimmer Biomet, Inc. · Class II · device

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 for recall

Device was distributed with the etching missing from the product.

Distribution

Distributed domestically to MI, MN, ND.

Key facts

Status: Terminated
Initiation date: 2017-06-29
Report date: 2018-01-10
Termination date: 2018-03-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0312-2018