Zimmer Orthopaedic Surgical Products, Disposable Cuff, 42in (107cm), Single Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit.
Hazard
The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
What You Should Do
Remedy
Consignees were first notified via certified mail on 10/27/2004. A follow up letter with 2 addtional lots were sent 11/11/2004.
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Products
Zimmer Orthopaedic Surgical Products, Disposable Cuff, 42in (107cm), Single Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fi
- Brand
- Zimmer Orthopaedic Surgical Products
- UPC
- Cat #60-7075-007-00, Lot #60171355. On 02/11/2005 the firm expanded the recall to include all cuffs including the following codes:Cat #60-7075-006-00, Lot #60154126, Single Port Cuff Cat #60-7075-056-00, Lot #60135939, Single Port Cuff, Cat #60-7075-003-00, Lot #60154124, Single Port Cuff, Cat #60-7075-003-00, Lot #60154124, Single Port Cuff, Cat #60-7075-004-00, Lot #60144536, Single Port Cuff, Cat #60-7075-007-00, Lot #60156860, Single Port Cuff, Cat #60-7075-052-00, Lot #60121031, Single Port Cuff, Cat #60-7075-001-00, Lot #60132141, Single Port Cuff, Cat #60-7075-003-00, Lot #60175349, Single Port Cuff, Cat #60-7075-006-00, Lot #60168614, Single Port Cuff, Cat #60-7075-003-00, Lot #60180950, Single Port Cuff, Cat #60-7075-006-00, Lot #60180452, Single Port Cuff, Cat #60-7075-054-00, Lot #60129625, Single Port Cuff, Cat #60-7075-004-00, Lot #60162833, Single Port Cuff, Cat #60-7075-007-00, Lot #60184637, Single Port Cuff, Cat #60-7075-006-00, Lot #60191899, Single Port Cuff, Cat #60-7075-053-00, Lot #60155642, Single Port Cuff, Cat #60-7075-005-00, Lot #60173812, Single Port Cuff, Cat #60-7075-001-00, Lot #60176467, Single Port Cuff, Cat #60-7070-003-00, Lot #60191898, Single Port Cuff, Cat #60-7075-003-00, Lot #60205584, Single Port Cuff, Cat #60-7075-003-00, Lot #60210874, Single Port Cuff, Cat #60-7075-006-00, Lot #60202395, Single Port Cuff, Cat #60-7075-056-00, Lot #60172186, Single Port Cuff, Cat #60-7075-053-00, Lot #60162834, Single Port Cuff, Cat #60-7075-054-00, Lot #60189989, Single Port Cuff, and Cat #60-7075-002-00, Lot #60180458, Single Port Cuff.
Units Affected
Total 53100 cuffs