Z-1606-2014Class II

Tennis Elbow Support, Neoprene***LATEX FREE"

Name: Z-1606-2014 Tennis Elbow Support, Neoprene***LATEX FREE"
Creator: Zimmer, Inc.
Published: 2014-03-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-03-19 / Terminated / root cause: labeling and UDI

FDA source

Zimmer, Inc. began a recall of Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains on 2014-03-19. FDA classified it as Class II and gives the reason as "During a transfer of products from a recently shutdown facility, the firm discovered raw material labeled as latex free actually contained latex". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1606-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-19
Posted: 2014-05-10
Terminated: 2015-04-14
Recalling firm: Zimmer GmbH
Product: Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains.
Product code: DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
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.
Root cause tag: labeling and UDI
FDA 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. [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
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.
Product codes and lots: Model #: 00-3448-003-00 through 00-3448-006-00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1606-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1603-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-09
Z-1604-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-09
Z-1605-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-09
Z-1606-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-09

Product code DWL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)