FDA Medical Device Recalls (openFDA)
LINK BIO CORP: LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
- Recall number
- Z-2445-2024
- Recalling firm
- LINK BIO CORP
- Product
- LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
- Status
- Open, Classified
- Initiated
- 2024-06-27
- Posted
- 2024-07-25
- Terminated
- not on file
- Reason
- The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process.
- Root cause
- Process change control
- Action
- On June 27, 2024 URGENT: MEDICAL DEVICE RECALL letters were sent via email to distributors. Actions to be taken by the Customer/User: Please check your inventory for this item and lot combination. If the markings are incorrect, as indicated in Section 5 below, please return the affected product to LinkBio. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return any affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned, should any affected product be identified. Please return any affected product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Quantity
- 8 units
- Distribution
- US Nationwide distribution in the states of FL, GA, KS, OH, WI.
- Lot, serial or model codes
- Item Number: 881-509/00; UDI-DI: 04026575310203; Lot number: C225066.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWT
- Firm FEI
- 3016534972
- Firm city
- Dover
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28