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Recall Observatory FDA recall evidence

Device 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

Z-1192-2018

March 01, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 79406
Status
Terminated
Classification
Class II
Quantity
24
Official record key
device-enforcement:Z-1192-2018

Official wording

Reason: Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.

Code information: Lot Number: 63716613, UDI: (01)00889024131606(17)270731(10)63716613; Lot Number: 63716614, UDI: (01)00889024131606(17)279731(10)63716614

Distribution pattern: Distributed in the following U.S. states: AZ, CA, CT, IN, MD, MI, MN, NJ, NY, OR, WA, and Puerto Rico. Distributed in China and India.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.