Stryker Orthopaedics Recalls Universal Acetabular Cup Positioner/Impactor
Stryker Howmedica Osteonics Corp. is recalling 3,768 units of the Universal Acetabular Cup Positioner/Impactor because the thread length may protrude past the dome of the acetabular trial or implant.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the source text reports a functional defect (thread protrusion) in a surgical instrument without explicit reports of patient injury or death, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 3,768 units of the Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200. The product is non-sterile and was distributed in the US and internationally.
The recall was initiated after Stryker Orthopaedics received reports that the thread length of the device protrudes past the dome of the acetabular trial or implant. This defect is associated with the Trident Universal Impactor/Positioner.
The affected units are identified by Catalog No. 2101-0200 and specific lot numbers listed in the agency's recall record. Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 3,768
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 (20)
- Catalog No: 2101-0200
- Lot Nos. SMM7A00
- SMM7A00L
- SMM7A02
- SMM7A02A
- SMM7A02E
- SMM7A02EE
- SMM7A01T
- SMM7A01TT
- SMM7A01TD
- SMM7A01TDD
- SMM7C02H
- SMM7C02
- SMM7C01
- SMM7C01T
- SMM7C01TT
- SMM7C01W
- SMM7E03
- SMM7E03A
- SMM7E00
Distribution
Distribution scope not specified by the agency.
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