CLASS II Device recall · Reported 7 Oct 2015 · FDA Enforcement Report
Guide Wires for orthopedic procedures recalled by Zimmer
Zimmer is recalling Zimmer Guide Wires for orthopedic procedures, distributed nationwide in the US. The recall was initiated on 27 Aug 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2820-2015
- FDA event ID
- 72132
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Aug 2015
- FDA classified
- 30 Sep 2015
- Reported
- 7 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 27 Aug 2015 | Recall initiated by company | |
| 30 Sep 2015 | Classified by FDA | +34 days |
| 7 Oct 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these same guide wires.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Zimmer Guide Wires for orthopedic procedures.
Where it was distributed
Worldwide Distribution - US (nationwide) including Puerto Rico and Virgin Islands., and to the countries of Canada, Brazil, Algeria, Mexico, Austria, Taiwan, Belgium, Hong Kong, Croatia, Singapore, Denmark, Bahamas, Egypt, Panama, Finland, Dominican Republic, France, Guatemala, Germany, Australia, Ireland, Japan,Italy, Haiti, Jordan, Malaysia, Kenya, India, Lebanon, Luxembourg, Malta, Mauritius, Morocco, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, United Kingdom and United Arab Emirates.
Questions about this recall
Is Guide Wires for orthopedic procedures recalled?
Yes. Zimmer recalled Guide Wires for orthopedic procedures on 27 Aug 2015. The recall is Class II and its status is Terminated. Recall number Z-2820-2015.
Why was it recalled?
Product labeling of these sterile guide wires (external carton label and patient record label) states a 10-year expiration date. Package testing supports a 5-year expiration date for these same guide wires.
Which lots are affected?
00-2228-024-00 2.4MM Diameter Bullet Tip Guide Wire; 00-2255-025-00 Humeral Smooth Guide Wire 2.4mm 70cm Length; 00-2255-026-00 Humeral Bullet Tip Guide Wire 2.4mm Diameter 70cm Length; 47-2237-033-00 Smooth Guide Wire 2.4mm Diameter 100cm Length; 47-2237-037-00 3.0MM Diameter Smooth Guide Wire 100cm Length; 47-2237-038-00 Bullet Tip Guide Wire 3.0mm Diameter 100cm Length; 47-2255-008-00 Ball Tip Guide Wire 2.4mm Diameter 70cm Length; 47-2255-008-01 Ball Tip Guide Wire 3.0mm Diameter 100cm Length All non-expired, distributed lots with a 10 year expiration date on the label.
Where was it sold?
Worldwide Distribution - US (nationwide) including Puerto Rico and Virgin Islands., and to the countries of Canada, Brazil, Algeria, Mexico, Austria, Taiwan, Belgium, Hong Kong, Croatia, Singapore, Denmark, Bahamas, Egypt, Panama, Finland, Dominican Republic, France, Guatemala, Germany, Australia, Ireland, Japan,Italy, Haiti, Jordan, Malaysia, Kenya, India, Lebanon, Luxembourg, Malta, Mauritius, Morocco, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, United Kingdom and United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Hip & Knee Implants recalls
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| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
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| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |