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Recall Observatory FDA recall evidence

Device product

HipLOC CHS Plate/Lag Screw Introducer

Z-0885-2016

February 16, 2016

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 73258
Status
Terminated
Classification
Class II
Quantity
23 units
Official record key
device-enforcement:Z-0885-2016

Official wording

Reason: A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked.

Code information: Catalog Number: 35-000263; and Lot Number Identification: 1807188, 1807189, 1943563, and 2577847.

Distribution pattern: US Distribution to the states of : MO, UT, AZ, IL, PA, KY, MI, NC, NJ, MN and GA., and Internationally to The Netherlands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked.