Stryker Recalls Tibial Punch Tower Assembly Due to Undersized Slot
Stryker Howmedica Osteonics is recalling 152 units of Tibial Punch Tower Assemblies because an undersized slot may prevent keel punches from being inserted.
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, and the source text describes a functional defect (undersized slot) that prevents the device from being used as intended, but it does not report any injuries, illnesses, or deaths.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 152 units of the Tibial Punch Tower Assembly (Catalog No. 8000-1089). The recall was initiated after a report indicated that a Tibial Keel Punch could not be inserted into the slot of the Tibial Punch Tower. The slot, which guides the stem of the keel punch into the channel of the tower, was determined to be undersized.
The affected product is a non-sterile surgical instrument used during primary Scorpio TKA procedures to prepare the tibia for baseplate implantation. The device is used in conjunction with Scorpio Tibial Keel Punches and Tibial Templates. The recall covers units with specific lot numbers, including RD6E087, RD6E187, RD6E083, and others listed in the agency record.
The product was distributed worldwide. Healthcare providers and facilities that have received these devices should stop using them and contact Stryker Howmedica Osteonics for instructions on how to return or replace the affected units.
The recalled product
- Product
- Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401. During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower (8000-1089) is used in conjunction with Scorpio Tibial Keel Punches…
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 152
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 Number 8000-1089. Lot Number(s): RD6E087
- RD6E187
- RD6E083
- RD6E082
- RD6C178
- RD5W268
- RD5W267
- RD5V260
- RD5W320
- RD5V240
- RD5V239
- RD5V238
- RD5N407
- RD5S104
- RD5S103
- RD5T177
- RD5T179
- RD5S259
- RD5T178
- RD5N406
Distribution
Distribution scope not specified by the agency.
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