Z-2247-2014Class II

6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer

Name: Z-2247-2014 6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
Creator: Zimmer, Inc.
Published: 2014-07-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-07-22 / Terminated / root cause: packaging

FDA source

Zimmer, Inc. began a recall of 6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer on 2014-07-22. FDA classified it as Class II and gives the reason as "Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only". 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-2247-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-22
Posted: 2014-08-16
Terminated: 2015-06-18
Recalling firm: Zimmer GmbH
Product: 6.5 mm Cancellous Screw 16 mm Thread Length Sterile zimmer
Product code: HWC Screw, Fixation, Bone
Reason for recall: Zimmer is recalling various trauma screws that failed a leak test due to damage of the inner cavity only.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: On 7/22/14, Zimmer sent recall notification to the consignees explaining the issue, identifying affected product, providing the health risks, and instructing the consignees what to do for the recall. Questions or concerns, please contact Zimmer at 1-877-946-2761.
Quantity in commerce: 47,682 units total
Distribution: National Distribution: AK, AL, AZ, CA, CT, DC, FL, GA, US VIRGIN ISLANDS, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, VA, WA, WI, WV, WY Foreign Distribution: Canada, Mexico, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL, CHINA, EL SALVADOR, ENGLAND, GERMANY, INDIA, ITALY, JAPAN, JORDAN, KOREA, NEW ZEALAND, SAUDI ARABIA, SINGAPORE, SPAIN, SWITZERLAND, TAIWAN, UAE
Product codes and lots: Item Number 47-4865-030, 035, 040, 045, 050, 055, 060, 065, 070, 075, 080, 085, 090, 100-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2247-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2244-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-15
Z-2245-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-15
Z-2246-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-15
Z-2247-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-15
Z-2248-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-15
Z-2249-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-15
Z-2250-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-15
Z-2251-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-15

Product code HWC

K112885Class IIZimmer Plates and Screws System Screws OnlyZimmer, Inc. / cleared 2011-12-19

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

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)