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Recall Observatory FDA recall evidence

Device product

Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400

Z-1208-2015

January 07, 2015

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 70297
Status
Terminated
Classification
Class II
Quantity
11- 6 consumed, 5 with distributors
Official record key
device-enforcement:Z-1208-2015

Official wording

Reason: The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.

Code information: Part Number: 010000589 Lot: 527400

Distribution pattern: Domestic: AL, FL, NY, TX Foreign: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.