Ossur

Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007. Inner tube serial numbers beginning with 1472 through 1677 are suspect. This number is not traceable to the customer. The recall will be based on shipments made during the period that these numbers were in use. (sold between 25th of August and October 2006)

Physical Medicine Devices

1

No

Nationwide in US plus Worldwide distribution in Canada, Austria, Switzerland, Czech Republic, Germany, Spain, France, United Kingdom, Greece, Israel, Italy, Netherlands and Norway.

Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules with integrated shock absorber, Model numbers RFXS0002, RFXS0003, RFLS0006 and RFL50007

US affected Serial Numbers (1) New units: 9056, 9062, 9063, 9088, 9089, 9090, 9092, 9094, 9095, 9096, 9097, 9099, 9100, 9101, 9102, 9103, 9104, 9105, 9106, 9107, 9108, 9109, 9110, 9111, 9112, 9113, 9114, 9115, 9116, 9117, 9118, 9127, 9129, 9130, 9159, 9160, 9162, 9163, 9166 and 9169.   (2) Repaired units: 5138, 5141, 6624 and 9098.

Physical Medicine Devices

1

No

Nationwide.

Ossur Total Knee Model Number 2100, external knee prosthesis.

Lot Number: 08060410

Orthopedic Devices

2

Yes

Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.

Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S

Lot Number: 08060408

Orthopedic Devices

2

Yes

Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.

Ossur 3" Ceramic Tip Pin, 4 pack, Model Number: 517DS

Lot Number: 08060305

Orthopedic Devices

2

Yes

Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.

Ossur 2 1/4" Ceramic Tip Pin, 4 pack, Model Number: 522CS