CLASS II Device recall · Reported 25 Dec 2019 · FDA Enforcement Report
Ascension¿ Silicone PIP-Silicone PIP Sz recalled
Integra Lifesciences Sales is recalling Ascension¿ Silicone PIP-Silicone PIP Sz 1, distributed nationwide in the US. The recall was initiated on 4 Nov 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-0691-2020
- FDA event ID
- 84320
- Recalling firm
- Integra Lifesciences Sales, Plainsboro, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Nov 2019
- FDA classified
- 16 Dec 2019
- Reported
- 25 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 4 Nov 2019 | Recall initiated by company | |
| 16 Dec 2019 | Classified by FDA | +42 days |
| 25 Dec 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
Product as listed by the FDA
Ascension¿ Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement of the proximal interphalangeal joint in patients with advanced osteoarthritis, post-traumatic arthritis and rheumatoid arthritis.
Where it was distributed
US Nationwide distribution in the state of CA.
Questions about this recall
Why was it recalled?
Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant
Which lots are affected?
Lot Number: Lot 192715T
Where was it sold?
US Nationwide distribution in the state of CA.
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 26 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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