Zimmer Orthopaedic Surgical 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 fill line. The product is packed 10 cuffs per unit. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Zimmer Orthopaedic Surgical Products
Lot Codes / Batch Numbers
Cat #60-7075-007-00, 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.
Products Sold
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.
Zimmer Orthopaedic Surgical Products is recalling Zimmer Orthopaedic Surgical Products, Disposable Cuff, 42in (107cm), Single Port, Single Bladder St due to The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
Recommended Action
Per FDA guidance
Consignees were first notified via certified mail on 10/27/2004. A follow up letter with 2 addtional lots were sent 11/11/2004.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026