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Recall Observatory FDA recall evidence

Device product

Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process.

Z-2032-2014

June 12, 2014

Class II

Product summary

Firm
Zimmer Manufacturing B.V.
Event
Event 68547
Status
Terminated
Classification
Class II
Quantity
496
Official record key
device-enforcement:Z-2032-2014

Official wording

Reason: Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.

Code information: Lot No. 62629432 Lot No. 62628759

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of India, Japan, China, Australia and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Two lots of screws were commingled. Screws with etching and machining for lot number 62629432 were packaged in bags labeled for lot number 62628759; and screws with etching and machining for lot number 62628759 were packaged in bags labeled for lot number 62629432. The affected product was distributed between 3/6/14 and 4/21/14.