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Recall Observatory FDA recall evidence

Device product

36MM COCR MODULAR HD -6MM

Z-1008-2018

September 15, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 79254
Status
Terminated
Classification
Class II
Quantity
23
Official record key
device-enforcement:Z-1008-2018

Official wording

Reason: One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.

Code information: 11-363660 UDI Number: (01) 00880304210509 (17) 270507 (10) 236840 Product Number: 11-363660 Lot Number: 236840

Distribution pattern: Outside USA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One piece from a different lot mixed with lot 236840 and is incorrectly etched as -6MM offset instead of +3MM offset. As the incorrect etching and related size difference affects the functional use of this product, the affected lot is being removed from the field.