CLASS II Device recall · Reported 27 Aug 2014 · FDA Enforcement Report
Cancellous Screw Fully Threaded Sterile zimmer recalled
Zimmer is recalling Cancellous Screw Fully Threaded Sterile zimmer, distributed nationwide in the US. The recall was initiated on 22 Jul 2014 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-2249-2014
- FDA event ID
- 68819
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jul 2014
- FDA classified
- 15 Aug 2014
- Reported
- 27 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 22 Jul 2014 | Recall initiated by company | |
| 15 Aug 2014 | Classified by FDA | +24 days |
| 27 Aug 2014 | 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
Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
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
6.5 mm Cancellous Screw Fully Threaded Sterile zimmer
Where it was distributed
National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE
Nationwide AlaskaAlabamaArizonaCaliforniaConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
Is Cancellous Screw Fully Threaded Sterile zimmer recalled?
Yes. Zimmer recalled Cancellous Screw Fully Threaded Sterile zimmer on 22 Jul 2014. The recall is Class II and its status is Terminated. Recall number Z-2249-2014.
Why was it recalled?
Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Which lots are affected?
Item Number 47-4865-030, 035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 100-00
Where was it sold?
National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE
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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