Zimmer ZMS Intramedullary Guide Wire Recall: Sterility Risk in Surgical Instruments
Zimmer Biomet recalls certain intramedullary guide wires due to potential sterility compromise from creases in the sealing area. Affected items have item number 47-2237-033-00 and expire before September 30, 2023.
Lower-risk recall
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Contact the company
What happened, in plain English
Zimmer Biomet is recalling specific intramedullary guide wires that may have creases in the sealing area, which could compromise sterility during surgery. This risk affects surgical instruments used in orthopedic procedures and requires immediate attention to prevent infection. Read more at govinfonow.com/recall/69558-zimmer-zms-intramedullary-guide-wire-recall-sterility-risk-in-surgical.
Source Summary by GovInfoNow · govinfonow.com/recall/69558-zimmer-zms-intramedullary-guide-wire-recall-sterility-risk-in-surgical · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0533-2019
Cite this page
“Zimmer ZMS Intramedullary Guide Wire Recall: Sterility Risk in Surgical Instruments.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69558-zimmer-zms-intramedullary-guide-wire-recall-sterility-risk-in-surgical. Based on FDA recall #Z-0533-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0533-2019%22&limit=1).
Why it’s dangerous
Creases in the sealing area opposite the chevron opening can compromise the product's sterility. This means the guide wire may not be sterile when used in surgery, potentially leading to infections in patients.
Who’s affected
Orthopedic surgeons and surgical teams using the recalled guide wires for procedures involving prosthesis implantation. Patients undergoing surgery with these instruments are at risk of infection if the sterility is compromised.
How to tell if you have this one
Check for the item number 47-2237-033-00 on the packaging. The guide wires expire before September 30, 2023, and are used in orthopedic surgeries for prosthesis implantation.
- Brand
Zimmer Biomet- Category
Medical device
All 13 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0530-2019 | 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.; All lots expiring prior to September 30, 2023 | 48320 |
| Z-0531-2019 | 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.; All lots expiring prior to September 30, 2023 | 4122 |
| Z-0532-2019 | 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.; All lots expiring prior to September 30, 2023 | 780 |
| Z-0533-2019 | 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.; All lots expiring prior to September 30, 2023 | 2080 |
| Z-0534-2019 | 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.; All lots expiring prior to September 30, 2023 | 9387 |
| Z-0535-2019 | 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.; All lots expiring prior to September 30, 2023 | 3358 |
| Z-0536-2019 | 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.; All lots expiring prior to September 30, 2023 | 8027 |
| Z-0537-2019 | 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.; All lots expiring prior to September 30, 2023 | 48320 |
| Z-0538-2019 | 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.; All lots expiring prior to September 30, 2023 | 57241 |
| Z-0539-2019 | 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.; All lots expiring prior to September 30, 2023 | 3764 |
| Z-0540-2019 | 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.; All lots expiring prior to September 30, 2023 | 12724 |
| Z-0541-2019 | 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.; All lots expiring prior to September 30, 2023 | 2519 |
| Z-0542-2019 | 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.; All lots expiring prior to September 30, 2023 | 1676 |
What to do — step by step
Check Product Details
Look for the item number 47-2237-033-00 and expiration date before September 30, 2023 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.2 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0533-2019 (October 22, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0533-2019 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.