CLASS II Device recall · Reported 29 May 2019 · FDA Enforcement Report
Drill, cannulated, 8x120mm, AO recalled by Zimmer
Zimmer is recalling Drill, cannulated, 8x120mm, AO, distributed in 42 states. The recall was initiated on 8 Apr 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-1480-2019
- FDA event ID
- 82642
- Recalling firm
- Zimmer, Winterthur, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Apr 2019
- FDA classified
- 23 May 2019
- Reported
- 29 May 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 8 Apr 2019 | Recall initiated by company | |
| 23 May 2019 | Classified by FDA | +45 days |
| 29 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
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Product as listed by the FDA
Drill, cannulated, 2.8x120mm, AO, Item Number ST502015628
Where it was distributed
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouri
Questions about this recall
Is Drill, cannulated, 8x120mm, AO recalled?
Yes. Zimmer recalled Drill, cannulated, 8x120mm, AO on 8 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-1480-2019.
Why was it recalled?
An investigation identified that the products were possibly manufactured from a different material than defined in the applicable specifications.
Which lots are affected?
All items marked with "Normed" are affected
Where was it sold?
The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY.
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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