FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains.
- Recall number
- Z-1606-2014
- Recalling firm
- Zimmer, Inc.
- Product
- Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains.
- Status
- Terminated
- Initiated
- 2014-03-19
- Posted
- 2014-05-10
- Terminated
- 2015-04-14
- Reason
- During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Model #: 00-3448-003-00 through 00-3448-006-00
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DWL
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28