The Recall Desk
HighFDA (Devices)·Z-1606-2014·Announced 2014-05-21

Zimmer Recalls Neoprene Tennis Elbow Supports Due to Latex Contamination

Zimmer, Inc. is recalling 649 units of Neoprene Tennis Elbow Supports because raw material labeled as latex-free actually contained latex.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves allergen mislabeling (latex) on a common allergen, which corresponds to a High severity score per the rubric, as no illnesses or injuries are reported in the source text.

Plain-English summary

Zimmer, Inc. is recalling 649 units of Neoprene Tennis Elbow Supports (Model # 00-3448-003-00 through 00-3448-006-00). The product is designed to provide compression and warmth for mild to moderate elbow strains and sprains.

The recall was initiated after the firm discovered that raw material labeled as latex-free actually contained latex during a product transfer from a recently shutdown facility. This mislabeling poses a risk to individuals with latex allergies.

The affected units were distributed worldwide, including in the United States (specifically in 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, and WV) and in Australia, Canada, Germany, Iraq, Italy, Saudi Arabia, Tunisia, and the United Arab Emirates. Consumers should stop using the product if they have a latex allergy and contact the manufacturer for instructions.

The recalled product

Product
Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains.
Manufacturer
Zimmer, Inc.
Affected units
649

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model #: 00-3448-003-00 through 00-3448-006-00

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →