Z-2058-2015Class II

A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw

Name: Z-2058-2015 A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Creator: Biomet, Inc.
Published: 2015-06-04
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-06-04 / Terminated / root cause: packaging

FDA source

Biomet, Inc. began a recall of A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw on 2015-06-04. FDA classified it as Class II and gives the reason as "Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection". 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-2058-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-04
Posted: 2015-07-10
Terminated: 2016-03-22
Recalling firm: Zimmer GmbH
Product: A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Product code: HRS Plate, Fixation, Bone
Reason for recall: Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
Root cause tag: packaging
FDA root cause: Packaging
Action: On 6/4/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for removing the affected product. 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. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday 8 a.m.to 5 p.m.
Quantity in commerce: 50 units
Distribution: Domestic: None. International: Netherlands and Japan
Product codes and lots: Part number:856135060 Lot: 061300

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2058-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2058-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-22	2015-07-10

Product code HRS

K111663Class IITrauma Internal Fixation SystemsDePuy Orthopaedics, Inc. / cleared 2012-03-12

Process control is the most common named cause of a device recall11 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)