The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1192-2018·Announced 2018-04-04

Zimmer Biomet Recalls Mismatched Hip Implant Packages Due to Sizing Error

Zimmer Biomet is recalling 24 hip implant packages labeled as size 7.5 Extended Offset Reduced Neck length that actually contained Size 4 Standard Reduced Neck length 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 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 medical device where a sizing mismatch could lead to improper fit or failure, representing a risk of harm even though specific injuries are not detailed in the source text.

Plain-English summary

Zimmer Biomet, Inc. is recalling 24 packages of Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length (Part Number: 00-7711-004-10). The recall was initiated because certain packages were incorrectly labeled as size 7.5 Extended Offset Reduced Neck length hip implants, but actually contained the Size 4 Standard Reduced Neck length taper hip implant.

The affected products are identified by Lot Numbers 63716613 and 63716614. The FDA has classified this as a Class II recall. The 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.

Healthcare providers and patients should verify the specific size and part number of the implanted device against the packaging labels. If a mismatch is identified, providers should contact Zimmer Biomet for instructions on corrective action. Patients who have had these implants should consult their orthopedic surgeon to review their surgical records and confirm the correct implant size was used.

The recalled product

Product
Zimmer M/L Taper Hip Prosthesis, 7711 Series, Femoral Stem 12/14 Neck Taper Plasma Sprayed Press-Fit Cementless Size 4 Standard Reduced Neck Length; Part Number: 00-7711-004-10
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
24

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 (4)

  • Lot Number: 63716613
  • UDI: (01)00889024131606(17)270731(10)63716613
  • Lot Number: 63716614
  • UDI: (01)00889024131606(17)279731(10)63716614

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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