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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves compromised sterility of a single-use surgical instrument used in orthopaedic surgery, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Zimmer Biomet, Inc. is recalling 8,027 units of the Zimmer Humeral Guide Wire - Ball Tip, 2.4 mm Diameter, 70 cm Length (Item Number: 47-2255-008-00). The recall affects all lots expiring prior to September 30, 2023. These single-use surgical instruments are used during orthopaedic surgery for the implantation of a prosthesis.
The recall was initiated because creases were found in the sealing area on the end opposite of the product's chevron opening. These creases may compromise the sterility of the product. The affected units were distributed worldwide, including in the United States, Canada, Australia, Brazil, Chile, Hong Kong, Japan, Malaysia, the Netherlands, Nicaragua, Singapore, and Taiwan.
Healthcare providers and facilities should stop using the affected guide wires and contact Zimmer Biomet for further instructions. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- 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.
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 8,027
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All lots expiring prior to September 30
- 2023
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 · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighZimmer Biomet Recalls Humeral Guide Wire Ball Tips Due to Packaging Seal Failure
FDA (Devices) · 2018-05-02
- ModerateZimmer Biomet Recalls Humeral Guide Wire Ball Tip Due to Packaging Design Verification
FDA (Devices) · 2018-02-14
- ModerateZimmer Biomet Recalls Guide Wires Due to Sterile Packaging Seal Failure
FDA (Devices) · 2018-05-02
- ModerateZimmer Biomet Recalls Humeral Guide Wires Due to Sterile Packaging Seal Failure
FDA (Devices) · 2018-05-02
- HighZimmer Biomet Recalls Humeral Guide Wires Due to Packaging Seal Failure
FDA (Devices) · 2018-05-02
- HighZimmer Biomet Recalls Trauma Guide Wires Due to Sterile Barrier Failure
FDA (Devices) · 2018-06-27