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
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
- Device type
- Other Medical Devices
Timeline
| 28 Mar 2019 | Recall initiated by company | |
| 9 May 2019 | Classified by FDA | +42 days |
| 15 May 2019 | Published 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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