Z-1683-2016Class II

Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap...

Name: Z-1683-2016 Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap...
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 Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw... 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-1683-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-04
Posted: 2016-05-16
Terminated: 2017-07-05
Recalling firm: Zimmer Manufacturing B.V.
Product: Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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: 1199
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: 63276979 63276976 63245682 63276975 63276977 63301523 63276980 63303436

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1683-2016
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 JDI

K840643Class IIHarris-Galante Porous Total Hip SysZimmer, Inc. / cleared 1984-04-17

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