The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
FDA Recall Z-1127-2013 · Posted 2013-04-17
Advertisement
Recalling FirmSynvasive Technology Inc
Recall StatusTerminated
Product CodeHSD
Date Initiated2013-03-14
Date Terminated2014-01-13
Product Quantity100 kits
Reason for Recall
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
Firm Action
An Urgent Medical Device Recall Notice letter dated March 21, 2013 was sent to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use; remove the products from inventory and complete and return the attached Response Form. For questions call 574-372-1570.
Root Cause
Packaging change control
Distribution Pattern
USA Nationwide Distributor including the state of IN
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement