CLASS II Device recall · Reported 21 Jan 2015 · FDA Enforcement Report
Timberline Anchored Lateral Fixed Retractable Sleeve recalled
Biomet Spine is recalling Timberline Anchored Lateral Fixed Retractable Sleeve, distributed in Arizona, California, New York, Puerto Rico, Tennessee, Texas. The recall was initiated on 22 Aug 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0983-2015
- FDA event ID
- 70070
- Recalling firm
- Biomet Spine, Broomfield, CO
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Aug 2013
- FDA classified
- 15 Jan 2015
- Reported
- 21 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 22 Aug 2013 | Recall initiated by company | |
| 15 Jan 2015 | Classified by FDA | +511 days |
| 21 Jan 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable 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. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. Spinal Surgical Device.
Where it was distributed
US Distribution to states of: AZ, CA, NY, TN and TX including PR.
Questions about this recall
Is Timberline Anchored Lateral Fixed Retractable Sleeve recalled?
Yes. Biomet Spine recalled Timberline Anchored Lateral Fixed Retractable Sleeve on 22 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-0983-2015.
Why was it recalled?
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.
Which lots are affected?
LOT Numbers: TU00053A, TU00053B and TU00118 Product Code: 86300205
Where was it sold?
US Distribution to states of: AZ, CA, NY, TN and TX including PR.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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