Z-1679-2016Class II

Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter...

Name: Z-1679-2016 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter...
Creator: Zimmer Manufacturing B.V.
Published: 2016-05-04
License: https://open.fda.gov/license/

Zimmer Manufacturing B.V. / initiated 2016-05-04 / Terminated / root cause: packaging

FDA source

Zimmer Manufacturing B.V. began a recall of Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini Magna-Fx Cannulated... on 2016-05-04. FDA classified it as Class II and gives the reason as "A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws". 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-1679-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-04
Posted: 2016-05-16
Terminated: 2017-07-05
Recalling firm: Zimmer Manufacturing B.V.
Product: Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 20 mm Length 00114205020 Mini Magna-Fx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 36 mm Length 00114205036 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 24 mm Length 00114205124 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 28 mm Length 00114205128 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 30 mm Length 00114205130 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 38 mm Length 00114205138 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 48 mm Length 00114205148 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Partially Threaded, 5.0 mm Diameter, 65 mm Length 00114205165 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 55 mm Length 00114605599 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 60 mm Length 00114606099 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, 32 mm Thread Length, 7.0 mm Diameter, 65 mm Length 00114606532 MagnaFx Cannulated Screw Fixation System Cannulated Bone Screw, Fully Threaded, 7.0 mm Diameter, 65 mm Length 00114606599 Mini MagnaFx Cannulated Screw Fixation System Small Cannulated Bone Screw, Fully Threaded, 5.0 mm Diameter, 12 mm Length 00114205012
Product code: HWC Screw, Fixation, Bone
Reason for recall: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: All distributors will be notified via electronic mail. Distributors with affected lots will also be notified via courier. Hospitals risk managers and surgeons will be notified via recall notification letter, dated May 4, 2016.
Quantity in commerce: 751
Distribution: Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
Product codes and lots: LOTS: 63290148 63295349 63290143 63295363 63290146 63296605 63295371 63295372 63308565 63308562 63303825 63259852 63295341

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1679-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1673-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16
Z-1674-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16
Z-1675-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16
Z-1676-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16
Z-1677-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16
Z-1678-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16
Z-1679-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16
Z-1680-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16
Z-1681-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16
Z-1682-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16
Z-1683-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16
Z-1684-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-25	2016-05-16

Product code HWC

K142442Class IIMagna-Fx and Mini Magna-Fx Cannulated Screw Fixation SystemZimmer, Inc. / cleared 2014-10-03

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)