Z-1944-2015Class II

Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue...

Name: Z-1944-2015 Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue...
Creator: Biomet, Inc.
Published: 2015-06-03
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-06-03 / Terminated

FDA source

Biomet, Inc. began a recall of Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures on 2015-06-03. FDA classified it as Class II and gives the reason as "Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1944-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-03
Posted: 2015-07-01
Terminated: 2015-12-22
Recalling firm: Zimmer GmbH
Product: Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Part Number: 905620 Lot: 824610 Gentle Threads Interference Screw 10x25mm Round Head is mixed with the Part Number: 905627 Lot: 753410 Gentle Threads Interference Screw 9x35mm Full Thread. If the incorrect screw is used various failures may occur which may ultimately lead to revision surgery or a delay in surgery.
FDA root cause: Mixed-up of materials/components
Action: On 6/3/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for locating and returning 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: 53 units
Distribution: Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.
Product codes and lots: Part Number: 905620 Lot: 824610

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1944-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1944-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-30
Z-1945-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-30

Product code HWC

K041274Class IIResorbable Interference ScrewArthrotek, Inc. / cleared 2004-07-28

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)