Z-1064-2018Class II

6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910)

Name: Z-1064-2018 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910)
Creator: Zimmer Biomet, Inc.
Published: 2017-12-07
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2017-12-07 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/8.0mm Cannulated Screw... on 2017-12-07. FDA classified it as Class II and gives the reason as "One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws". 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-1064-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-07
Posted: 2018-03-15
Terminated: 2020-04-17
Recalling firm: Zimmer GmbH
Product: 6.5mm x 125mm x 16mm Cannulated Screw, Item Number: 110009948 (UDI: (01)00887868111327 (17)270421 (10)120910) Product Usage: The 6.5/8.0mm Cannulated Screw System is part of a series of cannulated screws ranging from 4.0 to 8.0mm. Used in Slipped capital femoral epiphysis, Pediatric femoral neck fractures, Tibial plateau fractures, SI joint disruptions, Intercondylar femur fractures, Subtalar arthrodesis, and Fixation of pelvis and iliosacral joint.
Product code: HWC Screw, Fixation, Bone
Reason for recall: One lot of 3.5mm x 24mm Cortical Locking screws is labeled as 6.5mm x 125mm x 16mm Cannulated screws.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Zimmer Biomet sent an Urgent Medical Device Recall letter dated December 2017 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Review this notification n 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 and send to [email protected] within three (3) days. b. Request an International Return Authorization Number by emailing [email protected] c. For each return, send a copy of Attachment 1 to [email protected]. d. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. e. Mark "RECALL" on the outside of the returned cartons. 4. Return a copy of the your Inventory Return Certification and product return form. 5. For questions call customer service at 574-374-3071.
Quantity in commerce: 6
Distribution: Canada.
Product codes and lots: Lot: 120910

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1064-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1064-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-15

Product code HWC

K140891Class IIBiomet Cannulated Screw SystemBiomet, Inc. / cleared 2014-06-03

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)