Z-1675-2016Class II

Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801

Name: Z-1675-2016 Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
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 Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801 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-1675-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-04
Posted: 2016-05-16
Terminated: 2017-07-05
Recalling firm: Zimmer Manufacturing B.V.
Product: Zimmer universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
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: 200
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: LOT: 63297474

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1675-2016
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

K082527Class IIZimmer Universal Locking System: 3.5 Mm Locking Plates and ScrewsZimmer, Inc. / cleared 2008-12-18

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)