FDA (Devices) recall action 73156

Stryker Howmedica Osteonics Corp. recalled 18 products on 2016-03-02

The FDA (Devices) publishes a recall like this one as 18 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 18 pages.

Products: 18
Announced: 2016-03-02
Critical: 0
Units: 2,661,084

Why these products were recalled

During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–18 of 18

ModerateFDA (Devices)··2016-03-02
Stryker T2 K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker is recalling T2 K-Wires because the packaging seal integrity may be decreased, potentially affecting the sterility of the medical devices.
Product
Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
ModerateFDA (Devices)··2016-03-02
Stryker Gamma K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
ModerateFDA (Devices)··2016-03-02
Stryker Gamma3 K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma3 K-Wires because the packaging seal integrity may be decreased, potentially affecting the sterile barrier.
Product
Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
ModerateFDA (Devices)··2016-03-02
Stryker Gamma Guide Pin Recalled for Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma Guide Pins because a packaging review indicated that the seal integrity of the pouch may be decreased.
Product
Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
ModerateFDA (Devices)··2016-03-02
Stryker T2 K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
ModerateFDA (Devices)··2016-03-02
Stryker T2 Fixation K-Wire Recall Due to Packaging Seal Integrity Concerns
Stryker Howmedica Osteonics Corp. is recalling T2 Fixation K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
ModerateFDA (Devices)··2016-03-02
Stryker T2 Guidewire Recalled Due to Potential Pouch Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because the packaging seal integrity may be decreased, potentially affecting the sterile barrier.
Product
Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
ModerateFDA (Devices)··2016-03-02
Stryker T2 Guidewire Recalled for Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
ModerateFDA (Devices)··2016-03-02
Stryker T2 Guidewire Recalled for Potential Pouch Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
ModerateFDA (Devices)··2016-03-02
Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review indicated that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
ModerateFDA (Devices)··2016-03-02
Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
ModerateFDA (Devices)··2016-03-02
Stryker T2 K-Wire Recall Due to Potential Pouch Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
HighFDA (Devices)··2016-03-02
Stryker T2 K-Wire Recall Due to Potential Pouch Seal Integrity Issues
Stryker is recalling T2 K-Wires because a packaging review found the pouch seal integrity may be decreased, potentially affecting sterility.
Product
Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
ModerateFDA (Devices)··2016-03-02
Stryker T2 K-Wire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
ModerateFDA (Devices)··2016-03-02
Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased, potentially affecting sterility.
Product
Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
HighFDA (Devices)··2016-03-02
Stryker Recalls Metaizeau Intramedullary Pins Due to Packaging Seal Concerns
Stryker is recalling 147,838 Metaizeau Intramedullary Pins because packaging seal integrity may be decreased, potentially affecting sterility.
Product
Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
ModerateFDA (Devices)··2016-03-02
Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states
ModerateFDA (Devices)··2016-03-02
Stryker Gamma K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Distribution
0 states