Recall archive
94 recalls · page 3 of 4
Reported Nov 16, 2016
LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of…
FDA (openFDA device enforcement)
Reported Oct 19, 2016
Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details — Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal…
FDA (openFDA device enforcement)
Reported Sep 21, 2016
AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage, Rx only, Sterile R, Legal The AccuLIF PL Cages are indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Howmedica Osteonics Corp.
Matched: Brand — Since Stryker acquired the AccuLIF product in March of 2014, there have been Product Inquires (PIs) related to the PL implant confirming to have a…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 21, 2016
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 17, 2016
Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541-4-808, Lot 123, NDC M546654148080S…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Stryker Orthopaedic is voluntarily recalling the Triathlon Modular Handle because analysis revealed that the press fit specifications between the…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 3, 2016
Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.
FDA (openFDA device enforcement)
Reported Apr 27, 2016
VariAx Compression Plating System
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.
FDA (openFDA device enforcement)
Reported Mar 2, 2016
Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instructions For Use (IFU) states the device are sterilized…
18 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 9, 2015
Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s).
FDA (openFDA device enforcement)
Reported Nov 25, 2015
Stryker PCA 10 Degree Hooded Acetabular Insert ID 22mm, Part of the Howmedica PCA Total Hip System intended for use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details — Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the US, although the 22 mm size was inadvertently omitted…
FDA (openFDA device enforcement)
Reported Nov 18, 2015
Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints were received that specific lots of this product may…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 30, 2015
Trident 10 degrees X3 Insert 36 mm ID Catalog #623-10-36I Hip implant component
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a…
FDA (openFDA device enforcement)
Reported Aug 26, 2015
Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF 5530-G-209 (component of the Triathlon Total Knee…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 19, 2015
Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 Poly 19 mm i insert was in a package labeled as a…
1 more product in this recall
FDA (openFDA device enforcement)
Reported May 27, 2015
Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; Howmedica Osteonics Corp., A subsidiary of Stryker…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details — The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 20, 2015
Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (Kinemax Stem Extenders, 80 mm) there was a…
FDA (openFDA device enforcement)
Reported Mar 25, 2015
Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Potential for weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the Distal Capture Assembly.
FDA (openFDA device enforcement)
Reported 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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that…
FDA (openFDA device enforcement)
Reported 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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages…
FDA (openFDA device enforcement)
Reported Oct 22, 2014
Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Stryker Orthopaedics received a report indicating some of the Nail Insertion Sleeves had a different inner diameter than described on the package…
FDA (openFDA device enforcement)
Reported Jul 9, 2014
Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand — Tritanium Patella Inserter Instrument fracture during implantation. .
FDA (openFDA device enforcement)
Reported Apr 9, 2014
Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product details — Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4 was identified in a…
FDA (openFDA device enforcement)
Reported Feb 19, 2014
Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product · Product details — Stryker received reports from the field of the impaction plate dissociating/fracturing from the main body of the broach handle.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2014
Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Stryker Howmedica Osteonics Corp.
Matched: Brand · Product details — Stryker became aware during laboratory testing that there is a potential that the seal integrity of the outer pouch (sterile barrier) may be…
FDA (openFDA device enforcement)
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