The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1191-2018·Announced 2018-04-04

Zimmer Biomet Recalls Mismatched Hip Implant Packages

Zimmer Biomet is recalling 12 hip implant packages labeled as size 7.5 that actually contained size 4 implants.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (mismatched size) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Zimmer Biomet, Inc. is recalling 12 packages of Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length (Part Number: 00-7711-007-40). The recall is due to a labeling error where certain packages labeled as size 7.5 Extended Offset Reduced Neck length actually contained a Size 4 Standard Reduced Neck length taper hip implant.

The affected products were distributed in the U.S. states of Arizona, California, Connecticut, Indiana, Maryland, Michigan, Minnesota, New Jersey, New York, Oregon, and Washington, as well as in Puerto Rico, China, and India. The specific lot number is 63716611.

Consumers and healthcare providers should check their inventory for this specific part number and lot number. If the product is found, it should be removed from use and returned to the manufacturer or supplier for credit.

The recalled product

Product
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 7.5 Extended Offset Reduced Neck Length; Part Number: 00-7711-007-40
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
12

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 (2)

  • Lot Number: 63716611
  • UDI: (01)00889024131736(17)270731(10)63716611

Distribution

Distributed in 12 states:

Part of a larger recall action

This product is one of 2 recalled by Zimmer Biomet, 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 2 products in this recall →

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