Z-1172-2019Class II
Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
Integra LifeSciences Corporation / initiated 2019-03-08 / Terminated / root cause: labeling and UDI
Integra LifeSciences Corp. began a recall of Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T on . FDA classified it as Class II and gives the reason as "The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-1172-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Integra LifeSciences Corporation
- Product
- Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Left, Product No. LJV190T
- Product code
- HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
- Reason for recall
- The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
- Root cause tag
- labeling and UDI
- FDA root cause
- Other
- Action
- On March 8, 2019, the firm notified affected customers and distributors of the product issue via Urgent Medical Device Correction letter. The letter advised customers that the incorrect metallic coating material symbol had been printed on the implants labeling. Customers were asked to do the following: Please examine your inventory to determine if you have any Salto Talaris Total Ankle Prosthesis implants and/or Integra XT Revision Total Ankle Replacement System implants. Customers: 1. If you do have any impacted lots of Salto Talaris Total Ankle Prosthesis implants and/or Integra XT Total If you have any impacted lots of Salto Talaris Total Ankle Prosthesis implants and/or Integra XT Total Revision Ankle Replacement System implants, please be aware the correct material symbol is CP Ti. The IFU containing the correct material symbol can be accessed at the link below. Product removal is not required. Distributors: I1. f you have any impacted lots of Salto Talaris Total Ankle Prosthesis implants and/or Integra XT Total Revision Ankle Replacement System implants, please be aware the correct material symbol is CP Ti. The IFU containing the correct material symbol can be accessed at the link below. Product removal is not required. "2. We also kindly ask that you provide this letter to impacted customers who may have affected products. IFU Link: Integra XT: https://www.integralife.com/file/general/1551465297.pdf Salto Talaris: https://www.integralife.com/file/general/1546543287.pdf Customers and distributors were asked to 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]
- Quantity in commerce
- 2029
- Distribution
- Distributors in AL, CA, CT, FL, GA, HI, IA, ID, KS, KY, MD, MI, MO, MT, NC, NE, NJ, NM, NY, OH, OK,PA, TX, VA, WA, and WI.
- Product codes and lots
- 183349
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1150-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1151-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1152-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1153-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1154-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1155-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1156-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1157-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1158-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1159-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1160-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1161-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1162-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1163-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1164-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1165-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1166-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1167-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1168-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1169-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1170-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1171-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1172-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1173-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1174-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1175-2019 | Class II | Terminated | Voluntary: Firm initiated |
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