The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0937-2015·Announced 2015-01-14

Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle Recall

Stryker Orthobiologics is recalling Imbibe Aliquot Needle Bone Cement Needles due to potential breaches in the inner or outer packaging pouches.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, and the hazard is a potential packaging breach rather than a confirmed high-risk pathogen or structural defect.

Plain-English summary

Stryker Orthobiologics is recalling 2,155 units of the Imbibe Aliquot Needle Bone Cement Needle. The affected model numbers are 2110-0505, 2110-0524, 2110-0506, and 2110-0529. These needles are intended for the direct or percutaneous delivery of bone cement.

The recall was initiated because there is a potential for a breach in the inner or outer packaging pouches of all lots of the product. The recall covers all lots of the specified catalog numbers.

The affected products were distributed nationwide in the United States and in Canada. No specific illnesses or injuries have been reported in the source text. Users should stop using the product and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gauge x 4 inch 2110-0529 Diamond Needle, 11 gauge x 6 inch Intended Use: Can…
Manufacturer
Orthovita, Inc., dBA Stryker Orthobiologics.
Category
Medical Device — Surgical Instruments
Hazard
Affected units
2,155

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • 2110-0506
  • 2110-0524
  • 2110-0529.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Orthovita, Inc., dBA Stryker Orthobiologics. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Orthovita, Inc., dBA Stryker Orthobiologics.

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Same hazard · packaging breach

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