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
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
- Device type
- Heart & Vascular 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 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| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Spinal Rod Cutter recalled by Zimmer Biomet | Zimmer Biomet | Sterility | Nationwide |
| Device | CLASS II | Polaris 5 Spinal System and Polaris 5/Cypher Spinal System recalled | Zimmer Biomet | Device Malfunction | Nationwide |
| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D. recalled | Zimmer Biomet | Sterility | Nationwide |
| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled | Zimmer Biomet | Sterility | Nationwide |
| Device | CLASS II | ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled | Zimmer Biomet | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |