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

T7 Driver Solid AO recalled by Zimmer Biomet

Zimmer Biomet is recalling T7 Driver Solid 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: 13421A 13811A 14042B 14048B 14140A 14194B 14343A 14392A 14393A 14394A 14518A 14601A 14827B 14895C 15015B 15167B 15257A 15392A
Quantity recalled1924

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-1303-2019
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 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.

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 Solid AO ( recalled?

Yes. Zimmer Biomet recalled T7 Driver Solid AO ( on 28 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1303-2019.

Why was it recalled?

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

Which lots are affected?

Lot Numbers: 13421A 13811A 14042B 14048B 14140A 14194B 14343A 14392A 14393A 14394A 14518A 14601A 14827B 14895C 15015B 15167B 15257A 15392A

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.

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