Z-1303-2019Class II

T7 Driver Solid AO (Part Number 110018541)

Name: Z-1303-2019 T7 Driver Solid AO (Part Number 110018541)
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 Solid AO (Part Number 110018541) 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-1303-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-28
Posted: 2019-05-09
Terminated: 2020-06-02
Recalling firm: Zimmer GmbH
Product: T7 Driver Solid AO (Part Number 110018541) 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: 1924
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: 13421A 13811A 14042B 14048B 14140A 14194B 14343A 14392A 14393A 14394A 14518A 14601A 14827B 14895C 15015B 15167B 15257A 15392A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1303-2019
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)