Recall Z-0312-2018 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Zimmer Biomet, Inc.
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.
| Date | Jun 29, 2017 |
| Status | Terminated |
| Reason | Device was distributed with the etching missing from the product. |
| Root cause | Employee error |
| Action | The firm, Zimmer Biomet, sent an, "URGENT MEDICAL DEVICE RECALL REMOVAL" letter dated 6/28/2017 via email and FedEx on approximately 06/29/2017 to its consignees. The letter described the product, problem and actions to be taken. The consignees were Instructed to ensure appropriate personnel are notified, immediately locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement form by email to:corporatequality.postmarket@zimmerbiomet.com or fax to: 574-372-4265, return all affected products, and provide the names of any locations where product w |
| Quantity | 15 units |
| Distribution | Distributed domestically to MI, MN, ND. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093235 | RINGLOC + HYBRID ACETABULAR SYSTEM Biomet, Inc., Apr 30, 2010 |