Z-1086-2019Class II

Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip...

Name: Z-1086-2019 Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip...
Creator: Zimmer Biomet, Inc.
Published: 2019-03-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-03-01 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory... on 2019-03-01. FDA classified it as Class II and gives the reason as "Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa". 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-1086-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-01
Posted: 2019-04-04
Terminated: 2020-05-27
Recalling firm: Zimmer GmbH
Product: Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant Item Number: 103531 Product Usage: Accessory to total hip implant
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Zimmer Biomet conducted recall by letter dated 3/1/19 to the consumer/user level, including any intermediate wholesale or retail consignees. All distributors via email. Hospital risk managers and surgeons, as well as distributors with product notified Fed'x. Accounts asked to review notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory.3. Immediately return all affected product from your distributorship and from affected hospitals within your territory.a. Complete Attachment 1 Inventory Return Certification Form. Questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.
Quantity in commerce: 809 total
Distribution: Worldwide Distribution - US Nationwide Foreign: CHILE CHINA COSTA RICA GUJRAT,INDIA JAPAN MEXICO CDMX SINGAPORE
Product codes and lots: Lot Numbers/UDI Number 523430 (01) 00880304001961 (17) 280804 (10) 523430 523450 (01) 00880304001961 (17) 280727 (10) 523450 860840 (01) 00880304001961 (17) 280806 (10) 860840 860850 (01) 00880304001961 (17) 280809 (10) 860850 860860 (01) 00880304001961 (17) 280806 (10) 860860

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1086-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1086-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-10	2019-04-04
Z-1087-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-10	2019-04-04

Product code JWH

K912245Class IIAgc Revision Knee ProthesisBiomet, Inc. / cleared 1991-08-19

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)