FDA Medical Device Recalls (openFDA)
Biomet Spine, LLC: Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
- Recall number
- Z-0978-2015
- Recalling firm
- Biomet Spine, LLC
- Product
- Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
- Status
- Terminated
- Initiated
- 2013-08-22
- Posted
- 2015-01-14
- Terminated
- 2015-03-13
- Reason
- The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft.
- Root cause
- Component design/selection
- Action
- The firm, Lanx, sent their Consignees/customers a letter dated October 15, 2013. The letter described the product, problem and actions taken. Lanx and their distributors replaced the affected inventory with the conforming product. Please contact the Chief Compliance Officer at 303-501-8534 or by email: Randy.fesmire@lanx.com.
- Quantity
- 12 units
- Distribution
- US Distribution to states of: AZ, CA, NY, TN, and TX including PR.
- Lot, serial or model codes
- Model 8630-0204 Lots TU00052, TU00052A, and TU00117
- 510(k) numbers
- ["K123767"]
- PMA numbers
- not on file
- Product code
- OVD
- Firm FEI
- 3012447612
- Firm city
- Broomfield
- Firm state
- CO
- 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