Stryker Howmedica Osteonics Corp.

Complete recall history across all FDA and CPSC categories — 87 total recalls

Stryker Howmedica Osteonics Corp. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (87)

FDA medical device enforcement actions by Stryker Howmedica Osteonics Corp.. Showing most recent 50.

Date Product Reason Class
Apr 26, 2017 Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-4... Stryker is recalling Hoffmann LRF (Limb Reconstruction Frame) System Safety C... Class II
Dec 2, 2016 Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound... Reunion TSA Peg Alignment Sound broke during surgery. Class II
Nov 9, 2016 GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stry... A review of packaging revealed the seal integrity of the pouch may be comprom... Class II
Aug 29, 2016 LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, R... Stryker received several complaints describing incidence of harm secondary to... Class II
Aug 18, 2016 Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0... Stryker Orthopaedics has received reports of the thread length protruding pas... Class II
Aug 1, 2016 Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile,... Upon failure of the press-fit, the clamping sub components and pins could dis... Class II
Jul 1, 2016 Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reus... Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle. Class II
Jun 30, 2016 Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of ... Stryker discovered that a Tibial Nail and femoral Nail were incorrectly label... Class II
Jun 30, 2016 Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intend... Stryker discovered that a Tibial Nail and femoral Nail were incorrectly label... Class II
Jun 23, 2016 Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6... Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle bec... Class II
Jun 23, 2016 Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Seconda... It was reported that the secondary locking mechanism, and its corresponding c... Class II
Jun 3, 2016 Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, ... Impactors do not meet the required sterility assurance level (SAL) of 10-6 wh... Class II
Jan 21, 2016 Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended f... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporar... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for ... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intend... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temp... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended fo... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary st... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the tempor... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the ... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for th... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for ... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended fo... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended ... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended ... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended fo... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended... During a review of the packaging, it was determined that the seal integrity o... Class II
Jan 21, 2016 Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended f... During a review of the packaging, it was determined that the seal integrity o... Class II
Dec 23, 2015 Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures. The wire packages are correctly marked with a "NON-STERILE" label, however, t... Class II
Oct 15, 2015 Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmed... Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been ... Class II
Sep 29, 2015 Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, R... Stryker is recalling various lots of the Trithion MIS Modular Distal Capture ... Class II
Sep 21, 2015 Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tib... Stryker Orthopaedics has received two customer complaints regarding Duracon T... Class II
Sep 8, 2015 Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis... Complaints that the femoral head could not be assembled with its correspondin... Class II
Jun 25, 2015 Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant compo... it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all devic... Class II
Jun 24, 2015 Radio-Capitellum, Capitellum, Left, Large, Do Not Reuse, Rx Only. Indicated f... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum ... Class II
Jun 24, 2015 Recon, Radial Implant, Standard Stem, Size 1, Sterile, Do Not Reuse, Rx Only.... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum ... Class II
Jun 24, 2015 Sigmoid Notch, Radial Plate, Small, Sterile, Do Not Reuse, Rx Only. Intended... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum ... Class II
Jun 24, 2015 uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for r... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum ... Class II
Jun 24, 2015 rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement o... Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum ... Class II
May 29, 2015 Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 ... Stryker has received a report which identified that a Triathlon Tibial Bearin... Class II
May 29, 2015 Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly ... Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plu... Class II
May 12, 2015 ReUnion TSA Shoulder System, Standard SR Humeral Head Trial, 48X18, Catalog n... A package labeled as Part #5901-S-4818, Lot MAC7C14, standard humeral head t... Class II
Feb 27, 2015 Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extend... Stryker received four customer complaints reporting that inside the box label... Class II
Feb 12, 2015 Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Dist... Potential for weld disassociation of the cross pin, which could lead to loose... Class II
Feb 3, 2015 LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4... Three customer complaints were received for the same batch of V40 LFIT Vitall... Class II
Dec 15, 2014 Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E ... Five customer complaints were received for the same batch of Trident PSL Shel... Class II
Aug 15, 2014 Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., ... The peel strength of the inner blister may have been below internal validated... Class II
Aug 15, 2014 Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp.,... The peel strength of the inner blister may have been below internal validated... Class II

View all 87 device recalls →

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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