Z-0312-2018 Class II Terminated
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