CLASS II Device recall · Reported 29 Apr 2015 · FDA Enforcement Report
Crosscheck(R) Plating system, Lapidus CX plate Step, Right recalled
Wright Medical Technology is recalling Crosscheck(R) Plating system, Lapidus CX plate Step, Right, distributed nationwide in the US. The recall was initiated on 6 Mar 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1489-2015
- FDA event ID
- 70859
- Recalling firm
- Wright Medical Technology, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Mar 2015
- FDA classified
- 22 Apr 2015
- Reported
- 29 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Hip & Knee Implants
Timeline
| 6 Mar 2015 | Recall initiated by company | |
| 22 Apr 2015 | Classified by FDA | +47 days |
| 29 Apr 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
CROSSCHECK(R) Plating system, LAPIDUS CX plate, 2mm Step, Right, REF CCP-LPX2R. Orthopedic use.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Is Crosscheck(R) Plating system, Lapidus CX plate Step, Right recalled?
Yes. Wright Medical Technology recalled Crosscheck(R) Plating system, Lapidus CX plate Step, Right on 6 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1489-2015.
Why was it recalled?
The minor diameter, major diameter, thread pitch, and pitch on the Crosscheck are out of specification, which may result in intraoperative malfunction
Which lots are affected?
Lot Numbers: 35049-11A, 35049-11A-1, 362842, 36284-2-11
Where was it sold?
Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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