CLASS II Device recall · Reported 21 Mar 2018 · FDA Enforcement Report
Delta Cer Fem Hd T1 recalled by Zimmer Biomet
Zimmer Biomet is recalling Delta Cer Fem Hd T1, distributed in Texas. The recall was initiated on 30 Jun 2017 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-0992-2018
- FDA event ID
- 79242
- Recalling firm
- Zimmer Biomet, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Jun 2017
- FDA classified
- 13 Mar 2018
- Reported
- 21 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 30 Jun 2017 | Recall initiated by company | |
| 13 Mar 2018 | Classified by FDA | +256 days |
| 21 Mar 2018 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product may contain the presence of melted sterile packaging upon opening.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
DELTA CER FEM HD 32/0MM T1 Product Usage: For use in hip arthroplasty
Where it was distributed
US in the state of Texas
Questions about this recall
Is Delta Cer Fem Hd T1 recalled?
Yes. Zimmer Biomet recalled Delta Cer Fem Hd T1 on 30 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-0992-2018.
Why was it recalled?
Product may contain the presence of melted sterile packaging upon opening.
Which lots are affected?
part number: 650-1162 lot number: 2016030466
Where was it sold?
US in the state of Texas
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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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |