Recall Z-1135-2105— Zimmer Gmbh

Name: FDA recall Z-1135-2105
Creator: U.S. Food and Drug Administration
Published: 2014-12-17

Class II · Terminated

Class II FDA medical device recall by Zimmer Gmbh, initiated 2014-12-17, terminated 2015-09-23. It names one FDA 510(k) clearance: K954800. Product: CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease. Reason: Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision..

Recalling firm: Zimmer Gmbh
Classification: Class II
Status: Terminated
Initiated: 2014-12-17
Terminated: 2015-09-23
Firm location: Winterthur, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K954800 — APR HIP SYS W/CAL-COATED CAN STR TITANIUM (CSTI)Intermedics Orthopedics·cleared 1996-04-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease

Reason for recall

Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic infection is possible, which could lead to revision.

Data sourced from openFDA. This site is unofficial and independent of the FDA.