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U.S. Department of Health and Human Services

Class 2 Device Recall Tennis Elbow Support

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  Class 2 Device Recall Tennis Elbow Support see related information
Date Initiated by Firm March 19, 2014
Date Posted May 10, 2014
Recall Status1 Terminated 3 on April 14, 2015
Recall Number Z-1606-2014
Recall Event ID 68017
Product Classification Stocking, medical support (to prevent pooling of blood in legs - Product Code DWL
Product Tennis Elbow Support, Neoprene***LATEX FREE"

Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains.
Code Information Model #: 00-3448-003-00 through 00-3448-006-00
Recalling Firm/
Manufacturer		 Zimmer, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact
330-364-0989
Manufacturer 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.
FDA Determined
Cause 2		 Labeling mix-ups
Action 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
Quantity in Commerce 649 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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