ConforMIS (NSDQ:CFMS) said today that it expects to get its customized knee implants back on line this month, after an independent investigation of the problem behind the recall of some 950 of its customized knee implants found no further cause for concern.
Last August Bedford, Mass.-based ConforMIS said it had received 3 complaints of moisture on the patient-specific instrumentation used with the implants, although all 3 procedures went off without a hitch. The recall affected its iUni, iDuo, iTotal CR and iTotal PS devices made at a new plant in nearby Wilmington, Mass., between July 18 and August 28. The news prompted ConforMIS to pare its outlook for the rest of the year, leading investors to push CFMS share prices down 19%.
Today ConforMIS said an independent testing laboratory found that the moisture was ethylene glycol residue that “posed no significant health hazard to patients.” No residue was found on any of the implants tested by the lab, the company said.
“Based on the results of the investigation, ConforMIS believes that no monitoring of patients is necessary,” according to a press release. “The results of ConforMIS’ investigation suggest that the affected instrumentation underwent the commonly used ethylene oxide sterilization process in the presence of excess water and, as a result, contained small amounts of ethylene glycol residue. ConforMIS is in the process of completing final testing and implementing corrective actions, and expects to resume full production in October.”
ConforMIS affirmed the reduced guidance for fiscal 2015 it issued August 31, saying it still expects revenues of $64 million to $66 million, down from $72 million to $74 million. The company is slated to release its fiscal 3rd-quarter results Nov. 2.
CFMS shares lost -19.1% August 31, falling to $16 apiece, but closed yesterday at $18.90 each, off -4.4% since the recall news. The shares opened today at $18.76 each and were up 1.3% on the day to $19.17 shortly after the bell.
