Z-0691-2020Class II

Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW -

Name: Z-0691-2020 Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW -
Creator: Integra Lifesciences Sales Llc
Published: 2019-11-04
License: https://open.fda.gov/license/

Integra Lifesciences Sales LLC / initiated 2019-11-04 / Terminated / root cause: labeling and UDI

FDA source

Integra Lifesciences Sales Llc began a recall of Ascension Silicone PIP-Silicone PIP Sz 1, Model Number: SPIP5201WW - Product Usage: The Ascension Silicone PIP implant is intended for cementless replacement... on 2019-11-04. FDA classified it as Class II and gives the reason as "Silicone PIP Implant mislabeled as a size 1 implant on the outer packaging when in fact the package contained a size 0 implant". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0691-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-04
Posted: 2019-12-16
Terminated: 2020-05-05
Recalling firm: Integra Lifesciences Sales LLC
Product: 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.
Product code: KYJ Prosthesis, Finger, Constrained, Polymer
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
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Integra notified by letter consignee via courier service, facsimile or email between November 4th and 6th, 2019, advising reason for recall, health risk and action to take: confirm that the device was actually implanted as part of the above-referenced surgery and, if so, please confirm the date of that surgery. 2. Complete the attached Acknowledgement Form and return the completed form by email or fax indicating receipt and review of this notification. Keep a copy of the form for your records. Should you have any questions regarding these instructions, please contact Customer Service Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: [email protected] Outside USA: 781-565-1401
Quantity in commerce: 9 units
Distribution: US Nationwide distribution in the state of CA.
Product codes and lots: Lot Number: Lot 192715T

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0691-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0691-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-25	2019-12-16

Product code KYJ

K082231Class IIAscension Silicone PipAscension Orthopedics, Inc. / cleared 2009-01-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)