Z-2248-2014 Class II Terminated

Recalled by Zimmer, Inc. — Warsaw, IN

FDA device recall Z-2248-2014 was initiated by Zimmer, Inc. on Jul 22, 2014 and is designated Class II. Reason for recall: Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only. The recall status is terminated (terminated Jun 18, 2015). Affected quantity: 47,682 units total.

Recall Details

Product Type
Devices
Report Date
Aug 27, 2014
Initiation Date
Jul 22, 2014
Termination Date
Jun 18, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
47,682 units total

Product Description

6.5 mm Cancellous Screw 32 mm Thread Length Sterile zimmer

Reason for Recall

Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.

Distribution Pattern

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

Code Information

Item Number 47-4865-045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 100-02

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-2248-2014
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.