| | Class 2 Recall
OSS Reamer Sleeve |  |
| Date Posted |
December 04, 2012 |
| Recall Number |
Z-0472-2013 |
| Product |
OSS Reamer Sleeve REF132-472662 KNEE REAMER SLEEVE 13.0 thru 20.0 STAINLESS STEEL
The OSS Knee Reamer Sleeves are primarily used to guide the bullet tip of cylindrical reamers during the tibial preparation in OSS procedures. They are reusable. |
| Code Information |
Part Numbers 32-472662, 13.0 thru 20.0
Lot 154590, 156980, 519470, 519480, 542290, 628890, 755530
|
Recalling Firm/
Manufacturer |
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989 |
| For Additional Information Contact |
Audrey Daenzer
574-372-1570
|
Reason for
Recall |
Biomet has initiated this action following an investigation which identified that the thin shaft reamer may get stuck and not slide into the sleeve.
|
| Action |
The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated November 1, 2012 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately locate, discontinue use of and remove the product from circulation; and return recalled devices with directions to distribute notices, if product was further distributed; and to complete and return the enclosed FAX Back Response Form within three (3) business days to FAX # 574-372-1683. Distributors were charged with locating and returning products to Biomet ATTN: Return Goods-Building B RECALLS RGA#: _, Biomet, Inc., 56 East Bell Drive, Warsaw, IN 46580.
Questions should be directed to the Field Action Coordinator at (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m. |
| Quantity in Commerce |
36 |
| Distribution |
Worldwide distribution: USA (nationwide) and countries of: Japan and Netherlands. |
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