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Recall Observatory FDA recall evidence

Device product

Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.

Z-0787-2013

November 05, 2012

Class II

Product summary

Firm
Exactech, Inc.
Event
Event 64028
Status
Terminated
Classification
Class II
Quantity
26 Units
Official record key
device-enforcement:Z-0787-2013

Official wording

Reason: Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.

Code information: Catalog No. 130-3253, Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53, Serial Numbers 2479873 - 2479898.

Distribution pattern: Distributed in the states of TN, FL, VA, WA and NV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.