CLASS II Device recall · Reported 12 Dec 2018 · FDA Enforcement Report
Zimmer Smooth Guide Wire - Bullet Tip Diameter Length recalled
Zimmer Biomet is recalling Zimmer Smooth Guide Wire - Bullet Tip Diameter Length, distributed nationwide in the US. The recall was initiated on 22 Oct 2018 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-0537-2019
- FDA event ID
- 81394
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Oct 2018
- FDA classified
- 30 Nov 2018
- Reported
- 12 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 22 Oct 2018 | Recall initiated by company | |
| 30 Nov 2018 | Classified by FDA | +39 days |
| 12 Dec 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
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 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.
Where it was distributed
Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN
Questions about this recall
Is Zimmer Smooth Guide Wire - Bullet Tip Diameter Length recalled?
Yes. Zimmer Biomet recalled Zimmer Smooth Guide Wire - Bullet Tip Diameter Length on 22 Oct 2018. The recall is Class II and its status is Terminated. Recall number Z-0537-2019.
Why was it recalled?
Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility
Which lots are affected?
All lots expiring prior to September 30, 2023
Where was it sold?
Worldwide - US Nationwide Distribution Foreign: CANADA AUSTRALIA BRAZIL CHILE HONG KONG JAPAN MALAYSIA NETHERLANDS NICARAGUA SINGAPORE TAIWAN
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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|---|---|---|---|---|---|
| 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 |