Z-1135-2105Class II

CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals...

Name: Z-1135-2105 CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals...
Creator: Zimmer Gmbh
Published: 2014-12-17
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-12-17 / Terminated / root cause: packaging

FDA source

Zimmer Gmbh began a recall of CoCr Femoral Head - indicated for hip arthroplasty for noncemented use in skeletally mature invididuals undergoing primary surgery for rehabilitating hips... on 2014-12-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1135-2105
Classification: Class II
Status: Terminated
Initiated: 2014-12-17
Posted: 2015-02-20
Terminated: 2015-09-23
Recalling firm: Zimmer GmbH
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
Product code: MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
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.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: On 12/17/2014, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected distributors and hospital Risk Managers with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospital Risk Managers and distributors with affected inventory were also notified via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call the customer call center at 1-800-348-2759.
Quantity in commerce: 6109
Distribution: Domestic: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MS, MA, MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY International: Canada, Japan
Product codes and lots: Item numbers: 7210-22-000; 7210-22-350; 7210-22-800; 7210-26-000; 7210-26-035; 7210-26-350; 7210-26-800; 7210-28-000; 7210-28-004; 7210-28-400; 7210-28-800; 7210-32-000; 7210-32-004; 7210-32-400; 7210-32-800. Lot #'s: 61487412, 61516918, 61525215, 61533617, 61582735, 61417397, 61487413, 61417398, 61393996, 61393997, 61417401, 61417402, 61487414, 61487415, 61487416, 61487417, 61487418, 61487420, 61487422, 61487423, 61495211, 61495212, 61500247, 61516884, 61516885, 61516886, 61516888, 61525212, 61525213, 61533606, 61533607, 61533608, 61538022, 61538024, 61538026, 61554502, 61565073, 61565079, 61565081, 61565082, 61582736, 61417403, 61487424, 61487425, 61487426, 61495218, 61516903, 61516904, 61525214, 61533612, 61565084, 61565085, 61577701, 61582737, 61417399, 61487427, 61487428, 61487429, 61495210, 61516881, 61516882, 61533605, 61538021, 61543660, 61565071, 61565072, 61487443, 61565088, 61487447, 61487450, 61500252, 61525210, 61533616, 61565091, 61565104, 61582738, 61487453, 61500245, 61525209, 61565102, 61394048, 61487455, 61500250, 61538042, 61577704, 61487456, 61565101, 61382197, 61394027, 61394029, 61417404, 61417405, 61487571, 61487572, 61487573, 61487574, 61487575, 61487576, 61487577, 61495217, 61516893, 61516894, 61516896, 61516897, 61516898, 61525224, 61525225, 61525226, 61533610, 61538041, 61543661, 61565106, 61565112, 61565119, 61565125, 61382207, 61393990, 61417407, 61487578, 61487579, 61487580, 61487581, 61495237, 61516921, 61516922, 61525230, 61538057, 61543828, 61565116, 61565124, 61582745, 61394050, 61417406, 61487582, 61487583, 61487584, 61500251, 61516927, 61525227, 61525228, 61565109, 61565121, 61402292, 61487585, 61516917, 61525229, 61565122

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1135-2105
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1132-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-20
Z-1133-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-20
Z-1134-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-20
Z-1135-2105	Class II	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-20
Z-1136-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-20

Product code MEH

K954800Class IIApr Hip Sys W/cal-Coated Can Str Titanium (Csti)Intermedics Orthopedics / cleared 1996-04-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)