Z-1604-2014 Class II Terminated
FDA device recall Z-1604-2014 was initiated by Zimmer, Inc. on Mar 19, 2014 and is designated Class II. Reason for recall: During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex. The recall status is terminated (terminated Apr 14, 2015). Affected quantity: 2,222 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2014
- Initiation Date
- Mar 19, 2014
- Termination Date
- Apr 14, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,222 units
Product Description
Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment and support of many types of knee injuries or following surgical and nonsurgical correction.
Reason for Recall
During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
Distribution Pattern
Worldwide Distribution - US Nationwide in the states of: AK, AZ, CA, FL, GA, IA, IL, IN, LA, MD, MI, MO NC, NE, NV, NY, OH, OK, OR, PA, RI, SD, TX, UT, VA, VT, WA, WI & WV and countries of: AUSTRALIA, CANADA, GERMANY, IRAQ, ITALY, SAUDI ARABIA, TUNISIA & UNITES ARAB EMIRATES.
Code Information
Model #: 00-1747-001-00 through 00-1747-005-00
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1604-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026