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Recall Observatory FDA recall evidence

Device product

CORAIL Cementless Femoral Stem HA Coated Standard Size 11, Catalog No. 3L92511

Z-2521-2018

June 21, 2018

Class II

Product summary

Firm
DePuy Orthopaedics, Inc.
Event
Event 80240
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2521-2018

Official wording

Reason: Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.

Code information: 5307603 5300997

Distribution pattern: Accounts in AL, CA, CO, GA< IL, LA, ME, NC, NH, NY, OR, TX, UT, and WA. Foreign distribution to Belgium, Croatia, Cyprus, Denmark, Germany, Indonesia, Korea, Sweden, and Tunisia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.