PlainRecalls

Stryker Howmedica Osteonics Corp.

Compiled from official public sources by the editorial team.

87 recalls on record · Latest: May 31, 2017

Stryker Howmedica Osteonics Corp. Recall Insight

Stryker Howmedica Osteonics Corp. appears on 87 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.086% 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 May 31, 2017, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 37 entries, severity tagging shows 1 critical, 36 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 37 of 37 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 (37). The date window on this page runs from Jun 27, 2012 to Mar 11, 2015.

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 Mar 11, 2015

LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during su…

FDA Devices Moderate Feb 11, 2015

Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedur…

FDA Devices Moderate Oct 22, 2014

Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: Th…

FDA Devices Moderate Jul 9, 2014

Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the T…

FDA Devices Moderate Apr 9, 2014

Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: …

FDA Devices Moderate Feb 19, 2014

Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, …

FDA Devices Moderate Feb 19, 2014

Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, M…

FDA Devices Moderate Feb 5, 2014

Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryke…

FDA Devices Moderate Jan 1, 2014

Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.

FDA Devices Moderate Jan 1, 2014

Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.

FDA Devices Moderate Dec 18, 2013

1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive …

FDA Devices Moderate Dec 18, 2013

Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Scr…

FDA Devices Moderate Sep 4, 2013

Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total…

FDA Devices Moderate Sep 4, 2013

Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Pro…

FDA Devices Moderate Aug 7, 2013

GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single…

FDA Devices Moderate May 29, 2013

Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 0…

FDA Devices Moderate May 8, 2013

Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intraarticular f…

FDA Devices Critical Apr 24, 2013

ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to as…

FDA Devices Moderate Apr 17, 2013

Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subs…

FDA Devices Moderate Mar 27, 2013

Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee pro…

FDA Devices Moderate Mar 20, 2013

Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100

FDA Devices Moderate Jan 23, 2013

Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.

FDA Devices Moderate Jan 16, 2013

Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp…

FDA Devices Moderate Jan 2, 2013

Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fr…

FDA Devices Moderate Dec 12, 2012

Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate…

FDA Devices Moderate Dec 12, 2012

Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Dr…

FDA Devices Moderate Nov 28, 2012

Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects…

FDA Devices Moderate Nov 28, 2012

Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6525-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects…

FDA Devices Moderate Nov 21, 2012

Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a component …

FDA Devices Moderate Nov 14, 2012

Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate…

FDA Devices Moderate Oct 10, 2012

Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. T…

FDA Devices Moderate Aug 1, 2012

ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Co…

FDA Devices Moderate Aug 1, 2012

Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401. During primary Sco…

FDA Devices Moderate Aug 1, 2012

Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Ho…

FDA Devices Moderate Jul 25, 2012

Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in …

FDA Devices Moderate Jul 18, 2012

Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, M…

FDA Devices Moderate Jun 27, 2012

Stryker Howmedica Osteonics Accolade Offset Rasp Handle Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France ZAC Satol…

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Data Sources

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

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.