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POLYAX®LOCKING CORTICAL SCREW
Biomet Orthopedics, LLC · Model 8550-45-550 · UDI-DI 00887868058905
10
510(k) clearances
779
Adverse events
14
Recalls
97
Facilities
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.