CLASS II Device recall · Reported 15 May 2019 · FDA Enforcement Report

T7 Driver Cannulated AO recalled by Zimmer Biomet

Zimmer Biomet is recalling T7 Driver Cannulated AO (, distributed nationwide in the US. The recall was initiated on 28 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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
Quantity recalled5885

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1302-2019
FDA event ID
82640
Recalling firm
Zimmer Biomet, Warsaw, IN
Classification
Class II
Status
Terminated
Recall initiated
28 Mar 2019
FDA classified
9 May 2019
Reported
15 May 2019
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

28 Mar 2019Recall initiated by company
9 May 2019Classified by FDA+42 days
15 May 2019Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential of fracture, bending or shearing of the driver.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide AlaskaAlabamaArkansasArizonaConnecticutFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesota

Questions about this recall

Is T7 Driver Cannulated AO ( recalled?

Yes. Zimmer Biomet recalled T7 Driver Cannulated AO ( on 28 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1302-2019.

Why was it recalled?

There is a potential of fracture, bending or shearing of the driver.

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Zimmer Biomet

All 873

Other Heart & Vascular Devices recalls

All 6,199