DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries or following surgical correction.
Recall
- Recall Number
- Z-1603-2014
- Event Number
- 68017
- Firm
- Zimmer, Inc.
- FEI Number
- 1000220733
- Product Code
- DWL
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- March 19, 2014
- Posted
- May 10, 2014
- Terminated
- April 14, 2015
- Address
- 1800 W Center St, Warsaw, IN, 46580-2304
Description
DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries or following surgical correction.
During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
Zimmer sent an Urgent: Device Removal Letters dated April 8, 2014 to their customers. The letter identified the affected product, probllem and actions to be taken. Customers were instructed to review this notification, iIdentify and quarantine the affected product to prevent further distribution or use, complete the attached Response Form and return it via email. [email protected]. Return affected product to: Zimmer Surgical Attn: QA/RA Dept.- Recall 200 West Ohio Avenue Dover, Ohio 44622 USA Please include a copy of the Response Form with the shipment. For returns outside the US, please email [email protected] obtain an IRA (international return authorization) number. The IRA request should include the part number(s) being returned and the quantity. Please write the associated IRA number on the outside of the box. 4. Zimmer will credit your account for returned Drop-Lok" Knee Braces, Cartilage Knee Braces, Hinged Knee Supports, or Neoprene Tennis Elbow Supports. Please return a copy of the completed response form along with your returned product to ensure proper credit. Important: Please distribute this notification to all personnel within your organization who need to be aware. If you have further transferred affected product(s), please provide the customer's information on the Business Response Form to Zimmer. For questions call 330-354-0989
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.
131 units