FDA Device recall Z-0399-2019
StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade…
- FDA Device
- Class II
- terminated
- Published 2018-11-14
On 2018-11-14 the FDA classified a Class II recall of StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade… by Zimmer Biomet, citing there is a potential for comingling of the 43MM and 51 MM molds.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0399-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-21 |
| Published | 2018-11-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
Product
StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medical grade silicone with a 316L stainless steel reinforcement stem. They are designed to be filled with polymethylmethacrylate/gentamicin bone cement, or equivalent, by injecting with a dispenser/gun into the mold. After the cement cures, the temporary spacers are to be removed from the molds with the reinforcement remaining as the core of the spacer, and placed into the joint space. The spacers remain in place (180 days or less) until the second stage of the two-stage procedure is performed to implant a conventional hip joint prosthesis.
Reason
There is a potential for comingling of the 43MM and 51 MM molds
Identifiers
| code_info | Item Number 431207 Lot # 705550, UDI - (01)00880304447165(17)270927(10)705550 Item Number 431209 Lot # 705570, UD…Item Number 431207 Lot # 705550, UDI - (01)00880304447165(17)270927(10)705550 Item Number 431209 Lot # 705570, UDI - (01)00880304447141(17)270916(10)705570 Lot # 705580, UDI - (01)00880304447141(17)270916(10)705580 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0399-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.