FDA-Device2018-01-10Class II
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.
Zimmer Biomet, Inc.
Hazard
Device was distributed with the etching missing from the product.
Sold states
Distributed domestically to MI, MN, ND.
Affected count
15 units
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0312-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief