Zimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure
Zimmer Biomet is recalling specific trauma guide wires because packaging defects may allow sterile barrier breaches, creating a potential risk of infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (infection risk from sterile barrier failure) where the source text does not explicitly report that injuries or illnesses have occurred, fitting the criteria for a High severity score.
Plain-English summary
Zimmer Biomet, Inc. is recalling various trauma guide wires, including the Ball Tip Guide Wire 3.2mmx55cm (Catalog No. 469055). The recall is due to insufficient packaging design verification and an occurrence rate of complaints for sterile barrier failure that exceeds expected levels.
The affected guide wires are intended to be used as guide pins for the insertion of implants, such as cannulated screws and intramedullary nails, and for drilling bone. The packaging configuration used for these devices has the potential for sterile barrier breach, which leads to a possible risk of infection for patients.
The recall involves 1,234 units distributed worldwide, including the United States (nationwide), Argentina, South Korea, Chile, Colombia, Trinidad and Tobago, El Salvador, Costa Rica, Canada, Australia, Japan, and the Netherlands. Healthcare providers and facilities should stop using the affected devices and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- BALL TIP GUIDE WIRE 3.2MMX55CM; 469055 Intended to be used as a guide pin for insertion of implants (cannulated screws and/or intramedullary nails). Bone nail guidewire. Intended for drilling bone.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 1,234
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 13 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · infection
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateZimmer Biomet Recalls Guide Wires Due to Sterile Packaging Seal Failure
FDA (Devices) · 2018-05-02
- HighZimmer Biomet Recalls Smooth Guide Wires Due to Sterility Compromise
FDA (Devices) · 2018-12-12
- HighZimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterile Seal Failure
FDA (Devices) · 2018-05-02
- HighZimmer Biomet Recalls Guide Wires Due to Sterility Compromise
FDA (Devices) · 2018-12-12
- SevereZimmer Biomet Recalls Humeral Guide Wires Due to Sterility Compromise
FDA (Devices) · 2018-12-12
- ModerateZimmer Biomet Recalls Humeral Guide Wire Ball Tip Due to Packaging Design Verification
FDA (Devices) · 2018-02-14