The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1603-2014·Announced 2014-05-21

Zimmer Drop Lok Knee Brace Recalled Due to Latex Contamination

Zimmer, Inc. is recalling Drop Lok Knee Braces because raw material labeled as latex-free was found to contain latex. The recall affects 131 units distributed in the US and internationally.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 a high-risk allergen (latex) mislabeling on a medical device, which fits the rubric criteria for a High severity score (3) due to the risk of harm without reported injuries.

Plain-English summary

Zimmer, Inc. is recalling 131 units of the Drop Lok Knee Brace, models 00-1746-001-00 through 00-1746-006-00. The product is used for the treatment, support, and rehabilitation of knee injuries or following surgical correction.

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

The affected units were distributed nationwide in the United States and in several countries, including Australia, Canada, Germany, Iraq, Italy, Saudi Arabia, Tunisia, and the United Arab Emirates. Consumers should stop using the product and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
DROP LOK" Knee Brace***LATEX FREE" Product Usage: Used in the treatment, support, and rehabilitation of many types of knee injuries or following surgical correction.
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Support
Hazard
Affected units
131

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 #: 00-1746-001-00 through 00-1746-006-00

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 →

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