FDA (Devices) recall action 81394

Zimmer Biomet, Inc. recalled 13 products on 2018-12-12

The FDA (Devices) publishes a recall like this one as 13 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 13 pages.

Products: 13
Announced: 2018-12-12
Critical: 0
Units: 202,318

Why these products were recalled

Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility

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.

1–13 of 13

HighFDA (Devices)··2018-12-12
Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 780 Humeral Guide Wires because creases in the packaging may compromise sterility. The product is a single-use surgical instrument.
Product
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Bullet Tip, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-026-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Distribution
0 states
HighFDA (Devices)··2018-12-12
Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 57,241 Natural Nail System Tear Drop Guide Wires because creases in the sealing area may compromise product sterility.
Product
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2490-097-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Distribution
0 states
HighFDA (Devices)··2018-12-12
Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 1,676 Pressure Sentinel Guide Wires because creases in the packaging seal may compromise sterility. The defect could increase the risk of infection during orthopaedic surgery.
Product
Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Distribution
0 states
HighFDA (Devices)··2018-12-12
Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 9,387 units of ZMS Intramedullary Fixation Smooth Guide Wires because creases in the sealing area compromise product sterility.
Product
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-037-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Distribution
0 states
HighFDA (Devices)··2018-12-12
Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling specific lots of M/DN Intramedullary Fixation Humeral Guide Wires because creases in the packaging may compromise sterility.
Product
Zimmer M/DN¿ Intramedullary Fixation Humeral Guide Wire - Smooth, 2.4 mm Diameter, 70 cm Length Item Number: 00-2255-025-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Distribution
0 states
SevereFDA (Devices)··2018-12-12
Zimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 8,027 Humeral Guide Wires because creases in the sealing area may compromise product sterility.
Product
Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length Item Number: 47-2255-008-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Distribution
0 states
HighFDA (Devices)··2018-12-12
Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires because creases in the sealing area may compromise product sterility.
Product
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2237-038-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Distribution
0 states
HighFDA (Devices)··2018-12-12
Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling Pressure Sentinel Guide Wires because creases in the sealing area compromise product sterility. The recall affects 48,320 units distributed worldwide.
Product
Zimmer Pressure Sentinel¿ Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Distribution
0 states
HighFDA (Devices)··2018-12-12
Zimmer Biomet Recalls Smooth Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling Smooth Guide Wires because creases in the sealing area may compromise product sterility. The recall affects 48,320 units distributed worldwide.
Product
Zimmer Smooth Guide Wire - Bullet Tip, 3.0 mm Diameter, 100 cm Length Item Number: 47-2255-008-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Distribution
0 states
SevereFDA (Devices)··2018-12-12
Zimmer Biomet Recalls Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 2,080 units of ZMS Intramedullary Fixation Smooth Guide Wires because creases in the packaging may compromise sterility.
Product
Zimmer ZMS¿ Intramedullary Fixation Smooth Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2237-033-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Distribution
0 states
HighFDA (Devices)··2018-12-12
Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Concerns
Zimmer Biomet is recalling 12,724 units of Natural Nail System Tear Drop Guide Wires because creases in the packaging may compromise sterility.
Product
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 3.0 mm Diameter, 70 cm Length Item Number: 47-2490-098-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Distribution
0 states
SevereFDA (Devices)··2018-12-12
Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterility Compromise
Zimmer Biomet is recalling 3,764 units of Natural Nail System Tear Drop Guide Wires because creases in the packaging seal may compromise sterility.
Product
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 100 cm Length Item Number: 47-2490-097-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Distribution
0 states
HighFDA (Devices)··2018-12-12
Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires
Zimmer Biomet is recalling Natural Nail System Tear Drop Guide Wires due to creases in the sealing area that compromise sterility.
Product
Zimmer Natural Nail¿ System - Tear Drop Guide Wire, 2.4 mm Diameter, 70 cm Length Item Number: 47-2490-098-01 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.
Category
Distribution
0 states