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.
Z-0312-2018
Product summary
- Event
- Event 78758
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 units
- Official record key
device-enforcement:Z-0312-2018
Official wording
Reason: Device was distributed with the etching missing from the product.
Code information: Model No. 11-116062, Lot No. 374670, UDI No. (01) 0 0880304 59316 9 (17) 270513 (10) 374670
Distribution pattern: Distributed domestically to MI, MN, ND.
Derived failure modes
-
Unknown
Device was distributed with the etching missing from the product.