* Smith & Nephew says has not yet seen FDA’s warning letter
* Says has taken remedial action to address earlier concerns
* Sees no supply problems, no patient incidents reported
LONDON, Dec 29 (Reuters) - Replacement joint maker Smith & Nephew SN.L said on Wednesday the supply of one of its hip devices would not be affected by U.S. regulator concerns over manufacturing procedures at its facility in Tuttlingen, Germany.
The U.S. Food and Drug Administration (FDA) said in a letter dated Dec. 21 that certain required tests were not performed and the company had failed to establish and maintain procedures to correct problems, identified in July, in the manufacture of the R3 Ceramic Acetabular Systems. [ID:nN28253847]
Smith & Nephew said it had not yet seen the contents of the letter, but said it had taken remedial action to solve issues raised by the FDA in July and could continue to meet demand for the device from production at its other plants. “The device is also made in Warwick, UK, and Memphis so there is no problem in supply,” a company spokesman said.
“The FDA raised the issue in July and Smith & Nephew has put in place remedial action,” he added. “Presumably the FDA is not happy with that remedial action but we do not know what the issue is.”
He said there had been no reports of patient incidents.
Shares in the company shed 2 percent earlier on Wednesday after the FDA's warning was reported. They were 0.8 percent lower at 680 pence by 1419 GMT, underperforming a 0.2 percent lower FTSE 100 index .FTSE. [ID:nLDE6BS0DN] (Reporting by Paul Sandle; editing by Louise Heavens)
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