Z-0716-2014Class II

Locking Cortical Screw 3.5mmX38mm REF 8161-35-038

Name: Z-0716-2014 Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Creator: Biomet, Inc.
Published: 2013-12-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-12-19 / Terminated / root cause: labeling and UDI

FDA source

Biomet, Inc. began a recall of Locking Cortical Screw 3.5mmX38mm REF 8161-35-038 on 2013-12-19. FDA classified it as Class II and gives the reason as "3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0716-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-19
Posted: 2014-01-10
Terminated: 2015-07-07
Recalling firm: Zimmer GmbH
Product: Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
Product code: HRS Plate, Fixation, Bone
Reason for recall: 3.5mmx38mm Locking Cortical Screw, implants are being recalled since an investigation identified that a 3.5mmx28mm Cortical Locking Screw is labeled as a 3.5mmx38mm Cortical Locking Screw.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: URGENT MEDICAL DEVICE RECALL notices were sent to all consignees on December 19, 2013. Distributors who have affected hospitals in their regions were notified and provided with a copy of the notice that went to each hospital. Consignees are being contacted on an individual basis in an attempt to reconcile the product 100%. Fax back forms were provided to all consignees in order for Biomet to track returns. Non-responders will be contacted on an individual basis.
Quantity in commerce: 52
Distribution: US Distribution including states of: AZ, CA, GA, IL, KY, MI, NC, NH, NY, OH, PA, SD, TX, UT, and VA.
Product codes and lots: Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0716-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0716-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-10

Product code HRS

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)