PlainRecalls

DePuy Mitek, Inc., a Johnson & Johnson Co.

35 recalls on record · Latest: Jun 14, 2023

DePuy Mitek, Inc., a Johnson & Johnson Co. Recall Insight

DePuy Mitek, Inc., a Johnson & Johnson Co. appears on 35 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.042% of the federal archive — a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Jun 14, 2023, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 35 entries, severity tagging shows 0 critical, 35 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 35 of 35 entries — unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (35). The date window on this page runs from Jul 11, 2012 to Jun 14, 2023.

Manufacturer-level browsing is useful when monitoring a single firm for patterns — whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current — deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement — always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Jun 14, 2023

DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization …

FDA Devices Moderate Jun 14, 2023

DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Mode…

FDA Devices Moderate Jun 14, 2023

DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Mod…

FDA Devices Moderate Jun 14, 2023

DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization…

FDA Devices Moderate Dec 18, 2019

Healix Knotless ADV BR 4.75 Suture Anchor

FDA Devices Moderate Oct 31, 2018

Mitek Screw and Washer Depth Gauge, Product Code 219024

FDA Devices Moderate May 16, 2018

LATARJET EXPERIENCE Sharp Curved Ostetome Product Usage: The Latarjet EXPERIENCE Instability Shoulder Set is intended to provide to the orthopedi…

FDA Devices Moderate Mar 7, 2018

1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation containers to the…

FDA Devices Moderate Jun 28, 2017

DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurr…

FDA Devices Moderate Jun 28, 2017

DePuy Mitek LATARJET EXPERIENCE Coracoid Drill Product Code: 288201 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent …

FDA Devices Moderate Jun 28, 2017

DePuy Mitek LATARJET EXPERIENCE Top Hat Tap Product Code: 288203 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent sh…

FDA Devices Moderate Jun 28, 2017

DePuy Mitek LATARJET EXPERIENCE-Combo Screw Driver Product Code: 288211 Product Usage: The Latarjet Cortical Screw set is intended to treat recu…

FDA Devices Moderate Jan 27, 2016

FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue du…

FDA Devices Moderate Jan 27, 2016

FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue duri…

FDA Devices Moderate Nov 20, 2013

DePuy Mitek FMS Intermediary Tubing with One-Way valve Product Code: 281142 Product Usage: The Intermediary Tubing for FMS¿ Fluid Management Sy…

FDA Devices Moderate May 15, 2013

DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instrument…

FDA Devices Moderate May 1, 2013

ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in general soft tissue approxim…

FDA Devices Moderate May 1, 2013

ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, inclu…

FDA Devices Moderate Dec 26, 2012

DePuy Mitek 11 MM Fully Fluted Reamer, Sterile Product Number: 232423 DePuy Mitek Sterile Reamers are intended to cut through cortical and cancel…

FDA Devices Moderate Oct 31, 2012

SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-c…

FDA Devices Moderate Oct 31, 2012

SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotat…

FDA Devices Moderate Oct 31, 2012

SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 SPIRALOK Anchors are primarily used to re-attach soft tissue to …

FDA Devices Moderate Oct 31, 2012

SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotat…

FDA Devices Moderate Oct 31, 2012

SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff…

FDA Devices Moderate Oct 31, 2012

SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-…

FDA Devices Moderate Oct 31, 2012

SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 SPIRALOK Anchors are primarily used to re-attach soft tissue to …

FDA Devices Moderate Oct 31, 2012

Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, b…

FDA Devices Moderate Oct 31, 2012

SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-c…

FDA Devices Moderate Oct 31, 2012

SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-c…

FDA Devices Moderate Oct 31, 2012

DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use …

FDA Devices Moderate Oct 31, 2012

SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff…

FDA Devices Moderate Oct 31, 2012

SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-…

FDA Devices Moderate Oct 31, 2012

SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-c…

FDA Devices Moderate Jul 11, 2012

Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Sid…

FDA Devices Moderate Jul 11, 2012

Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is …

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare DePuy Mitek, Inc., a Johnson & Johnson Co. with FORD →

Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds