Z-0312-2018 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
January 10, 2018
Initiation Date
June 29, 2017
Termination Date
March 7, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15 units

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.

Distribution Pattern

Distributed domestically to MI, MN, ND.

Code Information

Model No. 11-116062, Lot No. 374670, UDI No. (01) 0 0880304 59316 9 (17) 270513 (10) 374670