SURFIX
NEWDEAL · Model 186300ND · UDI-DI 10381780048541
5
510(k) clearances
781
Adverse events
14
Recalls
97
Facilities
Description
Stainless steel non sterile washer belonging to the Newdeal locking system fixation. The osteosynthesis screws are fixed to the bone through the plate holes, creating a single implant/screw unit. The system is locked by means of washers drilled into the threaded lipped sockets at the top of each hole, thus blocking each screw head.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-06-02 | CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. | One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates |
| 2018-11-20 | Zimmer Biomet, Inc. | One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 02 |
| 2018-11-20 | Zimmer Biomet, Inc. | One lot of product labeled 2.7mm x18mm Lock Screw Square Drive (Lot 029970) contains 20mm locking screws and one lot of product labeled 2.7mm x 20mm Lock Screw Square Drive (Lot 02 |
| 2016-01-29 | Biomet, Inc. | Components of the DVR ePAKs can oxidize during shipment and storage prior to use. A delay in surgery, less than 30 minutes, may occur if the surgical staff proceeds to re-steriliz |
| 2015-03-18 | Biomet, Inc. | A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number: 131227222 Lot: RM105E) was anodized green and should have been anodized gold per |
| 2009-05-01 | Zimmer Inc. | Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation. |
| 2009-05-01 | Zimmer Inc. | Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation. |
| 2009-05-01 | Zimmer Inc. | Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation. |
| 2009-05-01 | Zimmer Inc. | Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation. |
| 2009-05-01 | Zimmer Inc. | Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.