FDA Medical Device Recalls (openFDA)
Zimmer Inc.: SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
- Recall number
- Z-0029-2011
- Recalling firm
- Zimmer Inc.
- Product
- SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
- Status
- Terminated
- Initiated
- 2009-01-01
- Posted
- 2010-10-08
- Terminated
- 2011-01-05
- Reason
- The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events.
- Root cause
- Other
- Action
- The firm provided a revised surgical technique document to the Zimmer spine sales force in January, 2009. The firm will provide an Urgent Medical Device Correction notification to speedlink users through the sales force.
- Quantity
- 23,205 Units for ALL PRODUCTS IN THIS RECALL
- Distribution
- The devices are contained in implant cases stocked by Zimmer spine and made available to the Zimmer sales force for surgeries. They are not in general distribution.
- Lot, serial or model codes
- 10FW, 10GA, 13WZ, 14MF, 15ED, 15XX, 19KV, 20QA, 22JC, 27LK, 28NH, 29RC, 30NR, 32HL, 34ES, 34WD, 35JB, 35TA, 36FF, 36NY, 37XZ, 38PH, 38YG, 39JD, 39RJ, 45KB, 5PB, 6AX, 6JX and 8BN.
- 510(k) numbers
- ["K002082"]
- PMA numbers
- not on file
- Product code
- KWP
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28