Z-1302-2019Class II

T7 Driver Cannulated AO (Part Number 110018531)

Name: Z-1302-2019 T7 Driver Cannulated AO (Part Number 110018531)
Creator: Zimmer Biomet, Inc.
Published: 2019-03-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-03-28 / Terminated

FDA source

Zimmer Biomet, Inc. began a recall of T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone... on 2019-03-28. FDA classified it as Class II and gives the reason as "There is a potential of fracture, bending or shearing of the driver". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1302-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-28
Posted: 2019-05-09
Terminated: 2020-06-02
Recalling firm: Zimmer GmbH
Product: T7 Driver Cannulated AO (Part Number 110018531) Product Usage: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.
Product code: HWC Screw, Fixation, Bone
Reason for recall: There is a potential of fracture, bending or shearing of the driver.
FDA root cause: Under Investigation by firm
Action: Urgent Medical Device Removal and Notice of Discontinuation notification letters dated 3/28/19 were sent to customers. The letter identified the affected product problem and actions to be taken. For questions or concerns call customer service at 574-371-307.
Quantity in commerce: 5885
Distribution: Worldwide Distribution - US Nationwide in the states: AK, AL, AR, AZ, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC< SD< TN, TX, UT, VA, VT, WA, WI, and WY. The products were distributed to the following foreign countries: Australia, Canada, Costa Rica, Malaysia, Netherlands, and Singapore.
Product codes and lots: Lot Numbers: 13422A 13869A 13870A 14042A 14048A 14090A 14090B 14090C 14090D 14090E 14194A 14194C 14194E 14194F 14194G 14224A 14827A 14827C 14827D 14827E 14827F 14895A 14895B 15015A 15167A 15167C 15310A 15310B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1302-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1302-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-09
Z-1303-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-15	2019-05-09

Product code HWC

K142658Class IIBiomet Headless Compression and Twist-off ScrewsBiomet Manufacturing Corp / cleared 2014-11-13

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