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Smith & Nephew, Inc. · Model 122771 · UDI-DI 03596010069887

LXT Prescription
2
510(k) clearances
779
Adverse events
14
Recalls
97
Facilities

Description

STAINLESS STEEL HALF PIN 6MM X 70MM

Recalls

DateFirmReason
2022-06-02CHANGZHOU 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
2018-11-20Zimmer 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
2018-11-20Zimmer 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
2016-01-29Biomet, 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
2015-03-18Biomet, 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
2009-05-01Zimmer Inc.Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
2009-05-01Zimmer Inc.Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
2009-05-01Zimmer Inc.Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
2009-05-01Zimmer Inc.Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
2009-05-01Zimmer 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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Data 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.