—#126804

Product

Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.

FDA product code: DWL — Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Model #: 00-1773-002-00 through 00-1773-008-00

Why it was recalled

During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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. orporateQuality_PostMarket@zimmer.com. 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 Rhonda.duncan@zimmer.com 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

Recalling firm

Firm: Zimmer, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

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.

Timeline

Recall initiated: 2014-03-19
Posted by FDA: 2014-05-10
Terminated: 2015-04-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126804. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.