RecallRadar

FDA Device recall Z-1008-2018

36MM COCR MODULAR HD -6MM

On 2018-03-21 the FDA classified a Class II recall of 36MM COCR MODULAR HD -6MM by Zimmer Biomet, citing 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….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1008-2018
ClassificationClass II
Statusterminated
Initiated2017-09-15
Published2018-03-21
Last updated2026-09-13 11:54 UTC
CompanyZimmer Biomet
Distributionn/a

Product

36MM COCR MODULAR HD -6MM

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.

Identifiers

code_info11-363660 UDI Number: (01) 00880304210509 (17) 270507 (10) 236840 Product Number: 11-363660 Lot Number: 236840

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1008-2018%22

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